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Psoriasis: HELP
Articles from Bulgaria
Based on 34 articles published since 2010
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These are the 34 published articles about Psoriasis that originated from Bulgaria during 2010-2020.
 
+ Citations + Abstracts
Pages: 1 · 2
1 Review Use of Curcumin in Psoriasis. 2018

Nardo, Veronica Di / Gianfaldoni, Serena / Tchernev, Georgi / Wollina, Uwe / Barygina, Victoria / Lotti, Jacopo / Daaboul, Farah / Lotti, Torello. ·Department of Nuclear, Subnuclear and Radiation Physics, University of Rome "G. Marconi", Rome, Italy. · University G. Marconi of Rome, Dermatology and Venereology, Rome, Italy. · Medical Institute of Ministry of Interior Department of General, Vascular and Abdominal Surgery, Sofia, Bulgaria. · Städtisches Klinikum Dresden, Department of Dermatology and Allergology, 01067 Dresden, Germany. · Department of Biomedical Experimental and Clinical Sciences, University of Florence, Florence, Italy. · Institute of Dermatological and Regenerative Sciences, Florence, Italy. ·Open Access Maced J Med Sci · Pubmed #29484027.

ABSTRACT: Curcumin is a polyphenol derived from the golden spice turmeric, which is widely used for different purposes, such as culinary spice and alimentary addictive, make - up and, finally, as a natural product for the treatment of different diseases, especially for the chronic inflammatory ones. Recently, curcumin has been proposed as a valid and safe therapeutic option for psoriasis.

2 Review Use of biologics for psoriasis in Central and Eastern European countries. 2015

Rencz, F / Kemény, L / Gajdácsi, J Z / Owczarek, W / Arenberger, P / Tiplica, G S / Stanimirović, A / Niewada, M / Petrova, G / Marinov, L T / Kazandhieva, J / Péntek, M / Brodszky, V / Gulácsi, L. ·Department of Health Economics, Corvinus University of Budapest, Budapest, Hungary. · Semmelweis University Doctoral School of Clinical Medicine, Budapest, Hungary. · Department of Dermatology and Allergology, University of Szeged, Szeged, Hungary. · National Health Insurance Fund Administration of Hungary, Budapest, Hungary. · Department of Dermatology, Military Institute of Medicine, Warsaw, Poland. · Department of Dermatology, Charles University 3rd Medical Faculty, Prague, Czech Republic. · Dermatology Clinic 2, Colentina Clinical Hospital, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania. · Department of Clinical Medicine, University of Applied Health Sciences, Zagreb, Croatia. · Department of Experimental and Clinical Pharmacology, Medical University of Warsaw, Warsaw, Poland. · Department of Social Pharmacy and Pharmacoeconomics, Faculty of Pharmacy, Medical University, Sofia, Bulgaria. ·J Eur Acad Dermatol Venereol · Pubmed #26370506.

ABSTRACT: OBJECTIVES: To evaluate the use of biological agents for the treatment of psoriasis and to explore country-specific differences within six Central and Eastern European (CEE) countries, namely Bulgaria, Croatia, the Czech Republic, Hungary, Poland and Romania. METHODS: A literature overview on the epidemiology and disease burden of psoriasis in CEE was conducted. The number of patients treated with biologics was obtained from patient registries, ministries of health, national professional societies and health insurance funds. Biological treatment rates were estimated by two different methods: (i) as a proportion of all psoriasis patients of a country (assuming a common prevalence of psoriasis 2%) and (ii) per 100,000 population. Moreover, we provide a detailed comparison of drug coverage policies and guidelines regulating the treatment with biologics in psoriasis. RESULTS: On average 0.25% of all psoriasis patients, or five psoriasis patients out of 100,000 inhabitants are treated with biologics embedding a 14.6-fold difference between the six countries. Bulgaria, Croatia and Poland lag behind the other three countries in the use of biologics. The significant differences among CEE countries cannot be explained by variations in prices of biologics, cost-effectiveness or budget impact of biologics. It seems that the time since coverage decision, the fewer number of covered biologics, the more restrictive criteria to be eligible for covered treatment in terms of baseline Psoriasis Area and Severity Index and Dermatology Life Quality Index scores, and the maximum duration of treatment allowed are responsible for the majority of the differences. CONCLUSIONS: There exists a disconnect between the European psoriasis treatment guidelines and the various CEE country-specific biologic coverage eligibilities. The cost of biologic therapy for psoriasis is not solely and directly responsible for the different use rates amongst the CEE countries. Psoriasis may not be perceived by all payers as a serious disease that can be successfully treated in a cost-effective manner.

3 Review Psoriasis as a systemic disease. 2014

Grozdev, Ivan / Korman, Neil / Tsankov, Nikolai. ·Department of Dermatology and Venereology, Medical Faculty, Medical University-Sofia, 1 Saint Georgi Sofiiski Boulevard, 1431 Sofia, Bulgaria. Electronic address: igrozdev@abv.bg. · Murdough Family Center for Psoriasis, University Hospitals Case Medical Center, Cleveland, Ohio. · Department of Dermatology and Venereology, Tokuda Hospital-Sofia, Sofia, Bulgaria. ·Clin Dermatol · Pubmed #24767182.

ABSTRACT: Psoriasis is an inflammatory immune-mediated disease that affects the skin and has pathogenic effects with systemic impact. The relationship between psoriasis and comorbidities remains controversial. The hypothesis of a causative role of psoriasis in its cardiovascular and metabolic comorbidities is based on pathophysiologic concepts establishing a link between chronic inflammation in psoriasis, endothelial dysfunction, formation of atherosclerotic plaques, and the different compounds of metabolic syndrome. Psoriasis management has to be multidisciplinary. It implicates identification and treatment of psychological disorders, addictions, and associated cardiovascular and metabolic diseases, together with improvement of quality of life of patients.

4 Clinical Trial Phase III randomized study of the proposed adalimumab biosimilar GP2017 in psoriasis: impact of multiple switches. 2018

Blauvelt, A / Lacour, J-P / Fowler, J F / Weinberg, J M / Gospodinov, D / Schuck, E / Jauch-Lembach, J / Balfour, A / Leonardi, C L. ·Oregon Medical Research Center, Portland, OR, U.S.A. · University of Nice Sophia Antipolis, Nice, France. · Dermatology Specialists, Louisville, KY, U.S.A. · Mount Sinai School of Medicine, New York, NY, U.S.A. · Medical University, Pleven, Bulgaria. · Hexal AG, Holzkirchen, Germany. · Central Dermatology, St Louis, MO, U.S.A. ·Br J Dermatol · Pubmed #29917226.

ABSTRACT: BACKGROUND: Adalimumab is used to treat several inflammatory diseases, including plaque psoriasis. GP2017 is a proposed adalimumab biosimilar. OBJECTIVES: To assess the impact of multiple switches between GP2017 and reference adalimumab (ref-ADMB) following the demonstration of equivalent efficacy and similar safety and immunogenicity, in adult patients with active, clinically stable, moderate-to-severe plaque psoriasis. METHODS: This 51-week double-blinded, phase III study randomly assigned patients to GP2017 (n = 231) or ref-ADMB (n = 234) 80 mg subcutaneously at week 0, then 40 mg biweekly from week 1. At week 17, patients were rerandomized to switch (n = 126) or continue (n = 253) treatment. The primary end point was patients achieving ≥ 75% improvement in Psoriasis Area and Severity Index (PASI 75) at week 16, with equivalence confirmed if the 95% confidence interval (CI) for the difference in PASI 75 between treatments was ± 18%. The key secondary end point was the change from baseline to week 16 in continuous PASI. Other end points were PASI over time; PASI 50, 75, 90 and100; pharmacokinetics; safety; tolerability and immunogenicity for the switched and continued treatment groups. RESULTS: Equivalent efficacy between GP2017 and ref-ADMB was confirmed for the primary (66·8% and 65·0%, respectively; 95% CI -7·46 to 11·15) and key secondary end points (-60·7% and -61·5%, respectively; 95% CI -3·15 to 4·84). PASI improved over time and was similar between treatment groups at week 16, and the switched and continued groups from weeks 17 to 51. There were no relevant safety or immunogenicity differences between GP2017 and ref-ADMB at week 16, or the switched and continued groups from weeks 17 to 51. No hypersensitivity to adalimumab was reported upon switching. CONCLUSIONS: Following the demonstration of GP2017 biosimilarity to ref-ADMB, switching up to four times between GP2017 and ref-ADMB had no detectable impact on efficacy, safety or immunogenicity.

5 Clinical Trial Epidermal barrier and oxidative stress parameters improve during in 311 nm narrow band UVB phototherapy of plaque type psoriasis. 2018

Darlenski, Razvigor / Hristakieva, Evgeniya / Aydin, Ufuk / Gancheva, Desisslava / Gancheva, Tanya / Zheleva, Antoaneta / Gadjeva, Veselina / Fluhr, Joachim W. ·Department of Dermatology and Venereology, Trakia University, Stara Zagora, Bulgaria. Electronic address: darlenski@abv.bg. · Department of Dermatology and Venereology, Trakia University, Stara Zagora, Bulgaria. · Department of Chemistry and Biochemistry, Medical Faculty, Trakia University, Stara Zagora, Bulgaria. · Department of Dermatology and Allergy, Charité Universitätsmedizin, Berlin, Germany. ·J Dermatol Sci · Pubmed #29610017.

ABSTRACT: BACKGROUND: Psoriasis is a multi-systemic inflammatory disease that results from dysregulation between epidermal keratinocyte homeostasis and both innate and acquired immunity. Epidermal barrier defect has been described in psoriatic lesions. Furthermore an imbalance between pro-oxidative stress and antioxidant defense mechanisms are known in psoriasis patients. AIM: The aim of this study was to address the link between disease activity, epidermal barrier and systemic oxidative stress in the course of 311 nm narrow band ultraviolet B (NB-UVB) therapy of psoriasis. The dynamic of systemic oxidative stress parameters as well as local transepidermal water loss (TEWL) and stratum corneum hydration (SCH) was characterized before and after 311 nm NB-UVB therapy on the plaques of psoriasis vulgaris in comparison to untreated non-affected volar forearm sites of the same patients. MATERIAL AND METHODS: 22 patients with plaque type psoriasis vulgaris and 25 gender- and age-matched healthy controls were enrolled. We assessed the psoriasis area and severity index (PASI) and the dermatology life quality index (DLQI) for monitoring disease activity, severity and self-perceived DLQI impact as patient related outcome parameter. We measured non-invasively TEWL (Tewameter TM 300) and SCH (Corneometer CM 825) and the end product of lipid peroxidation - malondialdehyde (MDA), Reactive oxygen species (ROS), ascorbyl radicals (Asc) and detoxifying activity of catalase (CAT) were measured in the peripheral blood with spectrophotometric and EPR spectroscopy methods. RESULTS: Disease activity improved in all patients compared to baseline witnessed by significant decrease in PASI; (from 14.1 to 10.4; p < 0.0001) and DLQI (from 11.7 to 8.1; p < 0.0001). At baseline TEWL-values were significantly (p < 0.0001) higher on psoriatic plaques (16.8 g/h/m CONCLUSION: The presented data is shows that a clinical improvement of psoriatic plaques under NB-UVB therapy, shown in with a decreased PASI and reflected by an increase in quality of life has beneficial effects on epidermal barrier function, SCH and improvement of systemic oxidative stress parameters (ROS, MDA and Asc). We assume that the general improvement in the oxidative stress parameters along with epidermal barrier parameters reflects mainly the improvement of disease activity which overwrites the possible negative pro-oxidative effects of the UV treatment.

6 Clinical Trial Quality of life aspects of patients with psoriasis using a series of herbal products. 2016

França, K / Tirant, M / Hercogovấ, J / Novotny, F / Fioranelli, M / Gianfaldoni, S / Chokoeva, A A / Tchernev, G / Wollina, U / Roccia, M G / Lotti, T. ·Department of Dermatology and Cutaneous Surgery, Department of Psychiatry and Behavioral Sciences, Institute for Bioethics and Health Policy, University of Miami, Miller School of Medicine, Miami, FL, USA; Centro Studi per la Ricerca Multidisciplinare e Rigenerativa, Università Degli Studi "G. Marconi", Rome, Italy. · Psoriasis and Skin Clinic, Melbourne, Australia. · 2nd Medical Faculty, Charles University, Bulovka Hospital, Institute of Clinical and Experimental Medicine, Prague, Czech Republic. · PRO SANUM Ltd, Sanatorium of Prof. Novotný, Štěpánská Prague 1, Czech Republic. · Department of Nuclear Physics, Sub-nuclear and Radiation, G. Marconi University, Rome, Italy. · Dermatological Department University of Pisa, Pisa, Italy. · ”Onkoderma”-Policlinic for dermatology and dermatologic surgery, Sofia, Bulgaria; Department of Dermatology and Venereology, Medical University of Plovdiv, Medical faculty, Plovdiv, Bulgaria. · Medical Institute of Ministry of Interior (MVR), Department of Dermatology, Venereology and Dermatologic Surgery, Sofia, Bulgaria. · Department of Dermatology and Allergology, Academic Teaching Hospital Dresden-Friedrichstadt, Dresden, Germany. · University B.I.S. Group of Institutions, Punjab Technical University, Punjab, India. · Chair of Dermatology, University of Rome “G. Marconi” Rome, Italy. ·J Biol Regul Homeost Agents · Pubmed #27498669.

ABSTRACT: Psoriasis is a chronic inflammatory disease affecting 1-3% of the general population. Due to the chronic nature of the disease, patients suffer from substantial psychosocial impact and impaired quality of life. Dr Michaels® (also branded as Soratinex®), an Australian series of topical herbal products, has been showing promising results for the treatment of patients with chronic plaque psoriasis and consequent improvement in their quality of life. This study aims to access the changes in quality of life of patients with Psoriasis using an Australian series of herbal skin-care products Dr Michaels® (Soratinex®) for psoriasis. The aim of this study is to observe and analyze the impact of Dr Michaels® product family on the quality of life of patients with psoriasis, 566 patients completed the Dermatology Quality of Life Index (DQLI) questionnaire in their initial consultation and at 3 follow up consultations, over a 6 months period. At the end of the data collection, all patients’ answers were recorded and analyzed. The Psoriasis Area and Severity (PASI) Index were used to measure the severity and extent of psoriasis during the 3 consultations. The PASI for severe, moderate-severe, mild-moderate cases across time revealed a significant effect of the treatment within weeks, confirming the decreasing scores during the treatment. As well as PASI results, the final DLQI score showed a sensible reduction from mean =6.716 (at week 0) to 6.252 (at week 2), 4.015 (at week 6) and 2.407 (at week 10) signifying a 64.2% reduction of the initial score. This study demonstrates that Dr. Michaels® (Soratinex®) products, an Australian series of herbal-based skin products is effective for the treatment of psoriasis. This treatment also significantly improves patient’s quality of life.

7 Clinical Trial Efficacy and safety of Dr Michaels® (Soratinex®) product family for the topical treatment of psoriasis: a monitored status study. 2016

França, K / Novotny, F / Hercogovấ, J / Fioranelli, M / Gianfaldoni, S / Chokoeva, A A / Tchernev, G / Wollina, U / Tirant, M / Roccia, M G / Lotti, T. ·Department of Dermatology and Cutaneous Surgery, Department of Psychiatry and Behavioral Sciences, Institute for Bioethics and Health Policy, University of Miami, Miller School of Medicine, Miami, FL, USA; Centro Studi per la Ricerca Multidisciplinare e Rigenerativa, Università Degli Studi "G. Marconi", Rome, Italy. · PROSANUM Ltd, Sanatorium of Prof. Novotný, Štěpánská Prague 1, Czech Republic. · 2nd Medical Faculty, Charles University, Bulovka Hospital, Institute of Clinical and Experimental Medicine, Prague, Czech Republic. · Department of Nuclear Physics, Sub-nuclear and Radiation, Guglielmo Marconi University, Rome, Italy. · Dermatological Department University of Pisa, Pisa, Italy. · ”Onkoderma”-Policlinic for dermatology and dermatologic surgery, Sofia, Bulgaria; Department of Dermatology and Venereology, Medical University of Plovdiv, Medical faculty, Plovdiv, Bulgaria. · Medical Institute of Ministry of Interior (MVR), Department of Dermatology, Venereology and Dermatologic Surgery, Sofia, Bulgaria. · Department of Dermatology and Allergology, Academic Teaching Hospital Dresden-Friedrichstadt, Dresden, Germany. · Psoriasis and Skin Clinic, Melbourne, Australia. · University B.I.S. Group of Institutions, Punjab Technical University, Punjab, India. · Chair of Dermatology, University of Rome “G. Marconi” Rome, Italy. ·J Biol Regul Homeost Agents · Pubmed #27498668.

ABSTRACT: The aim of the study was to investigate the efficacy and safety of Michaels® (Soratinex®) remedies in patients suffering from chronic plaque psoriasis in a Czech population. Seventy-five (34 female/41 male) patients, aged 18-72 years old (mean age: 38.5 years) with mild to severe plaque psoriasis participated in the study. The products, including cleansing gel, ointment and skin conditioner, containing fruit acid complex, herbal oils and emulsifiers, were used twice daily and in the same manner for all the skin lesions. The study period was eight weeks. Histologic variables and various blood picture parameters, including FW, glucose, cholesterol, triacylglyceroles, bilirubin, GMT, ALT, AST, creatinine, uric acid and urea in blood were monitored, before and after therapy with Michaels® (Soratinex®) treatment. Assessment, using the Psoriasis Activity Severity Index (PASI) scores and photographic analysis, was done at time 0, and after 2, 4, 6 and 8 weeks. Patient’s improvement was determined by the percentage reduction of the PASI scores. Side effects and tolerability were also evaluated. After 8 weeks using Dr Michaels® (Soratinex®) treatment course, 5 patients had a moderate improvement, with the resolution of 25-50% of skin lesions; 11 patients showed a good improvement, with the resolution of 51-75% of lesions. Another 50 patients had an outstanding improvement, with the regression of 76-100% of lesions. Only 4 patients did not achieve an improvement of psoriasis. Six patients experienced folliculitis, which resolved without cessation of treatment. Three patients worsened and discontinued treatment. Six patients dropped out because of non-compliance. The blood results and histologic findings were all normal. Our investigation shows that Dr Michaels® (Soratinex®) products can be safely and successfully used in the treatment of chronic plaque psoriasis.

8 Clinical Trial An innovative, promising topical treatment for psoriasis: a Romanian clinical study. 2016

Gianfaldoni, S / Hercogovấ, J / Fioranelli, M / Chokoeva, A A / Tchernev, G / Wollina, U / Tirant, M / Novotny, F / Roccia, M G / Maximov, G K / França, K / Lotti, T. ·Dermatological Department University of Pisa, Pisa, Italy. · 2nd Medical Faculty, Charles University, Bulovka Hospital, Institute of Clinical and Experimental Medicine, Prague, Czech Republic. · Department of Nuclear Physics, Sub-nuclear and Radiation, G. Marconi University, Rome, Italy. · ”Onkoderma”-Policlinic for dermatology and dermatologic surgery, Sofia, Bulgaria; Department of Dermatology and Venereology, Medical University of Plovdiv, Medical faculty, Plovdiv, Bulgaria. · Medical Institute of Ministry of Interior (MVR), Department of Dermatology, Venereology and Dermatologic Surgery, Sofia, Bulgaria. · Department of Dermatology and Allergology, Academic Teaching Hospital Dresden-Friedrichstadt, Dresden, Germany. · Psoriasis and Skin Clinic, Melbourne, Australia. · PRO SANUM Ltd, Sanatorium of Prof. Novotný, Štěpánská Prague 1,Czech Republic. · University B.I.S. Group of Institutions, Punjab Technical University, Punjab, India. · Department “Medicinal Information and Non-interventional studies”, Bulgarian Drug Agency, Sofia, Bulgaria. · Department of Dermatology and Cutaneous Surgery, Department of Psychiatry and Behavioral Sciences, Institute for Bioethics and Health Policy, University of Miami, Miller School of Medicine, Miami, FL, USA; Centro Studi per la Ricerca Multidisciplinare e Rigenerativa, Università Degli Studi "G. Marconi", Rome, Italy. · Chair of Dermatology, University of Rome “G. Marconi” Rome, Italy. ·J Biol Regul Homeost Agents · Pubmed #27498667.

ABSTRACT: Psoriasis is a chronic inflammatory disease with negative impacts both physically and psychologically. It is a common disorder affecting 2-3% of the total world population, in some cases causing changes to the nail and joints as well as skin lesions. The cutaneous manifestations of psoriasis can vary in morphology and severity and therapy should be tailored accordingly. Even if today many therapeutic options are available for psoriasis treatment, none of them provide excellent clinical results without the risk of side effects. The authors investigate the efficacy of Dr. Michaels® (Soratinex®) natural products in the topical treatments of a group of psoriatic patients. Sixty-two patients (34 male/28 female) from Romania, aged 18-70 years (mean age: 52 years), affected by a mild to severe form of chronic plaque psoriasis were included in this study. Each patient has been treated with a triphasic application of Dr. Michaels® (Soratinex®) natural products, twice a day for six weeks. The products were applied on skin and scalp lesions, but not on the face, genital and flexures. The evaluation of the tested products was based on the PASI of each patient at time 0, 1, 2, 3, 4, 5, and 6 weeks. The tested products were ineffective in five of 57 patients. Eleven patients had a moderate improvement (PASI decrease 26-50%); 11 patients had a good improvement (PASI decrease 51-75%) and 30 patients an outstanding one (PASI decrease 76-100%). Twenty-three% of patients developed folliculitis that regressed upon discontinuation of the application. Five patients developed pruritus, which regressed spontaneously. The cosmetic effect was evaluated as indifferent by 44% of patients, as good by 40% of patients and as excellent by 16% of patients. Ninety-five% of patients stated that they would continue to use the tested products, because it was effective and with poor side effects since the products were natural. In our experimental study, the topical application of Dr. Michaels® (Soratinex®) natural products proved to be an effective natural therapeutic option for psoriasis treatment.

9 Clinical Trial Scalp psoriasis: a promising natural treatment. 2016

Wollina, U / Hercogovấ, J / Fioranelli, M / Gianfaldoni, S / Chokoeva, A A / Tchernev, G / Tirant, M / Novotny, F / Roccia, M G / Maximov, G K / França, K / Lotti, T. ·Department of Dermatology and Allergology, Academic Teaching Hospital Dresden-Friedrichstadt, Dresden, Germany. · 2nd Medical Faculty, Charles University, Bulovka Hospital, Institute of Clinical and Experimental Medicine, Prague, Czech Republic. · Department of Nuclear Physics, Sub-nuclear and Radiation, G. Marconi University, Rome, Italy. · Dermatological Department University of Pisa, Pisa, Italy. · ”Onkoderma”-Policlinic for dermatology and dermatologic surgery, Sofia, Bulgaria; Department of Dermatology and Venereology, Medical University of Plovdiv, Medical faculty, Plovdiv, Bulgaria. · Medical Institute of Ministry of Interior (MVR), Department of Dermatology, Venereology and Dermatologic Surgery, Sofia, Bulgaria. · Psoriasis and Skin Clinic, Melbourne, Australia. · PRO SANUM Ltd, Sanatorium of Prof. Novotný, Štěpánská Prague 1, Czech Republic. · University B.I.S. Group of Institutions, Punjab Technical University, Punjab, India. · Department “Medicinal Information and Non-interventional studies”, Bulgarian Drug Agency, Sofia, Bulgaria. · Department of Dermatology and Cutaneous Surgery, Department of Psychiatry and Behavioral Sciences, Institute for Bioethics and Health Policy, University of Miami, Miller School of Medicine, Miami, FL, USA; Centro Studi per la Ricerca Multidisciplinare e Rigenerativa, Università Degli Studi "G. Marconi", Rome, Italy. · Chair of Dermatology, University of Rome “G. Marconi” Rome, Italy. ·J Biol Regul Homeost Agents · Pubmed #27498666.

ABSTRACT: Psoriasis is a lifelong chronic inflammatory disease affecting 2-3% of the worldwide population. Scalp psoriasis is a particular form of psoriasis characterized by lesions on the scalp, which may occur isolated or in association with other skin lesions. The aim of this study was to investigate the efficacy and safeness of an innovative treatment of scalp psoriasis, which is based on the topical application of natural products. Fifty adult subjects with scalp psoriasis (23 females, 27 males) from different European dermatological centres were included in the study. Forty-six patients with severely infiltrated psoriatic lesions were invited to use the products of Dr Michaels® (Soratinex®), according to a three-phase application, twice a day (morning and evening). The other 4 patients followed a different regimen: after a shampoo in the evening, they applied the conditioner in the night and washed it in the morning with the cleansing gel. The application time of Dr Michaels® (Soratinex®) products was 8 weeks. The treatment was evaluated at 0, 1, 2, 3, 4, 5, 6, 7, and 8 weeks. The evaluation was based on the Psoriasis Scalp Severity Index (PSSI) and on a photographic analysis at each of the medical evaluation points. At the end of the study, all patients showed an outstanding improvement. Five patients referred a transient pruritus, which regressed spontaneously without discontinuing the application. No other side effects have been described. We observe that Dr Michaels® (Soratinex®) natural product family can be considered as a valid therapeutic tool for scalp psoriasis when considering the exclusion criteria. The tested products provided an outstanding improvement of lesions in all the patients, without side effects.

10 Clinical Trial Dr Michaels® (Soratinex®) product for the topical treatment of psoriasis: a Hungarian/Czech and Slovak study. 2016

Hercogovấ, J / Fioranelli, M / Gianfaldoni, S / Chokoeva, A A / Tchernev, G / Wollina, U / Tirant, M / Novotny, F / Roccia, M G / Maximov, G K / França, K / Lotti, T. ·2nd Medical Faculty, Charles University, Bulovka Hospital, Institute of Clinical and Experimental Medicine, Prague, Czech Republic. · Department of Nuclear Physics, Sub-nuclear and Radiation, G. Marconi University, Rome, Italy. · Dermatological Department University of Pisa, Pisa, Italy. · ”Onkoderma”-Policlinic for dermatology and dermatologic surgery, Sofia, Bulgaria; Department of Dermatology and Venereology, Medical University of Plovdiv, Medical faculty, Plovdiv, Bulgaria. · Medical Institute of Ministry of Interior (MVR), Department of Dermatology, Venereology and Dermatologic Surgery, Sofia, Bulgaria. · Department of Dermatology and Allergology, Academic Teaching Hospital Dresden-Friedrichstadt, Dresden, Germany. · Psoriasis and Skin Clinic, Melbourne, Australia. · PRO SANUM Ltd., Sanatorium of Prof. Novotný, Štěpánská Prague 1, Czech Republic. · University B.I.S. Group of Institutions, Punjab Technical University, Punjab, India. · Department “Medicinal Information and Non-interventional studies”, Bulgarian Drug Agency Sofia, Bulgaria. · Department of Dermatology and Cutaneous Surgery, Department of Psychiatry and Behavioral Sciences, Institute for Bioethics and Health Policy, University of Miami, Miller School of Medicine, Miami, FL, USA; Centro Studi per la Ricerca Multidisciplinare e Rigenerativa, Università Degli Studi "G. Marconi", Rome, Italy. · Chair of Dermatology, University of Rome “G. Marconi” Rome, Italy. ·J Biol Regul Homeost Agents · Pubmed #27498657.

ABSTRACT: Psoriasis is a chronic inflammatory T cell-mediated skin disease, affecting about 2% of Hungarian population. Genetic predisposition as well as environmental triggering factors, and innate immune processes play a role in its etiology. Treatment of psoriasis during the initial stages and first years of disease tend to be conservative and frequently based on topical agents. The aim of this study was to investigate and to describe the efficacy and safety of Dr Michaels® (Soratinex®) skin-care products for the topical treatment of stable chronic plaque psoriasis in a Hungarian population. Two-hundred-and-eight-six (120 female/166 male) patients, aged 10-80 years old (mean age 43 years) with mild to moderate plaque psoriasis had participated in the study. The products, including cleansing gel containing a coal tar solution, herbal oils and emulsifiers, were used twice daily and in the same manner for all the skin lesions. The study period was eight weeks. Assessment, using the Psoriasis Activity Severity Index (PASI) scores and photographic analysis, was done 2 weeks before treatment, at time 0, and after 2, 4, 6 and 8 weeks. Patient’s improvement was determined by the percentage reduction of the PASI scores. Side effects and tolerability were also evaluated. After 8 weeks treatment course, 46 patients had a moderate improvement, with the regression of 25-50% of skin lesions; 77 patients showed a good improvement, with the resolution of 51-75% of lesions. Another 115 patients had an outstanding improvement, with the regression of 76-98.9% of lesions. Only 13 patients did not achieve an improvement of psoriasis. Fifteen patients experienced folliculitis, which resolved after cessation of treatment. Seven patients worsened and discontinued treatment. Thirteen patients dropped out because of non-compliance. Our investigation demonstrates that Dr Michaels® (Soratinex®) products, an Australian treatment, can be used successfully in the treatment of stable chronic plaque psoriasis.

11 Clinical Trial Clinical evaluation of the effectiveness of “Dr Michaels®” (also branded as Soratinex®) products in the topical treatment of patients with plaque psoriasis. 2016

Fioranelli, M / Hercogovấ, J / Gianfaldoni, S / Chokoeva, A A / Tchernev, G / Wollina, U / Tirant, M / Novotny, F / Roccia, M G / Maximov, G K / França, K / Lotti, T. ·Department of Nuclear Physics, Sub-nuclear and Radiation, Guglielmo Marconi University, Rome, Italy. · 2nd Medical Faculty, Charles University, Bulovka Hospital, Institute of Clinical and Experimental Medicine, Prague, Czech Republic. · Dermatological Department University of Pisa, Pisa, Italy. · ”Onkoderma”- Policlinic for dermatology and dermatologic surgery, Sofia, Bulgaria; Department of Dermatology and Venereology, Medical University of Plovdiv, Medical faculty, Plovdiv, Bulgaria. · Medical Institute of Ministry of Interior (MVR), Department of Dermatology, Venereology and Dermatologic Surgery, Sofia, Bulgaria. · Department of Dermatology and Allergology, Academic Teaching Hospital Dresden-Friedrichstadt, Dresden, Germany. · Psoriasis and Skin Clinic, Melbourne, Australia. · PRO SANUM Ltd, Sanatorium of Prof. Novotný, Štěpánská Prague 1, Czech Republic. · University B.I.S. Group of Institutions, Punjab Technical University, Punjab, India. · Department “Medicinal Information and Non-interventional studies”, Bulgarian Drug Agency, Sofia, Bulgaria. · Department of Dermatology and Cutaneous Surgery, Department of Psychiatry and Behavioral Sciences, Institute for Bioethics and Health Policy, University of Miami, Miller School of Medicine - Miami, FL, USA; Centro Studi per la Ricerca Multidisciplinare e Rigenerativa. Università Degli Studi "G. Marconi", Rome, Italy. · Chair of Dermatology, University of Rome “G. Marconi” Rome, Italy. ·J Biol Regul Homeost Agents · Pubmed #27498655.

ABSTRACT: Psoriasis is generally considered as an autoimmune inflammatory cutaneous-systemic disease, with chronic course and high rate of recurrence, while its high risk of comorbidities affect the patients’ quality of life significantly. Despite the good therapeutic response, most of the available options show tendency for poor tolerance and high rate of occurrence of side effects. Therefore, the interest of patients and doctors to investigate the possibility of treating psoriasis with natural substances is not surprising. The aim of this study was to investigate the efficacy and safety of the herbal skin-care product Dr Michaels® (Soratinex®) for the management of chronic plaque psoriasis, within a 6 to 8 week treatment course. Thirty patients of both sexes, aged between 24 and 70 years with mild to moderate psoriasis vulgaris were included in this study. The products of Dr Michaels® (Soratinex®) were applied in sequence: cleansing gel, ointment after 3-4 minutes and tonic care (for the fire-smeared ointment) 2 times per day for restorative care and cleansing gel for psoriasis within scalp 3 times a week. The study lasted six weeks. The severity and extent of the lesions were evaluated by PASI score (Psoriasis Area and Severity Index). Based on the obtained result, the products of “Dr Michaels® (Soratinex®)” have proved to be effective in the treatment of mild and moderate psoriasis vulgaris. In the study group, no improvement was observed in 10% of patients, a slight improvement in 20%, good in 40% and very good in 16.6% of patients.

12 Clinical Trial A clinical examination of the efficacy of preparation of Dr Michaels® (also branded as Soratinex®) products in the treatment of psoriasis. 2016

Hercogovấ, J / Fioranelli, M / Gianfaldoni, S / Chokoeva, A A / Tchernev, G / Wollina, U / Tirant, M / Novotny, F / Roccia, M G / Maximov, G K / França, K / Lotti, T. ·2nd Medical Faculty, Charles University, Bulovka Hospital, Institute of Clinical and Experimental Medicine, Prague, Czech Republic. · Department of Nuclear Physics, Sub-nuclear and Radiation, G. Marconi University, Rome, Italy. · Dermatological Department University of Pisa, Pisa, Italy. · ”Onkoderma”-Policlinic for dermatology and dermatologic surgery, Sofia, Bulgaria; Department of Dermatology and Venereology, Medical University of Plovdiv, Medical faculty, Plovdiv, Bulgaria. · Medical Institute of Ministry of Interior (MVR), Department of Dermatology, Venereology and Dermatologic Surgery, Sofia, Bulgaria. · Department of Dermatology and Allergology, Academic Teaching Hospital Dresden-Friedrichstadt, Dresden, Germany. · Psoriasis and Skin Clinic, Melbourne, Australia. · PRO SANUM Ltd, Sanatorium of Prof. Novotný, Štěpánská Prague 1, Czech Republic. · University B.I.S. Group of Institutions, Punjab Technical University, Punjab, India. · Department “Medicinal Information and Non-interventional studies”, Bulgarian Drug Agency Sofia, Bulgaria. · Department of Dermatology and Cutaneous Surgery, Department of Psychiatry and Behavioral Sciences, Institute for Bioethics and Health Policy, University of Miami, Miller School of Medicine - Miami, FL, USA; Centro Studi per la Ricerca Multidisciplinare e Rigenerativa. Università Degli Studi "G. Marconi", Rome, Italy. · Chair of Dermatology, University of Rome “G. Marconi” Rome, Italy. ·J Biol Regul Homeost Agents · Pubmed #27498653.

ABSTRACT: Psoriasis is a chronic inflammatory disease with negative impacts both physically and psychologically. It is a common disorder affecting 2-3% of the total world population, in some cases causing changes to the nail and joints as well as skin lesions. The cutaneous manifestations of psoriasis can vary in morphology and severity and therapy should be tailored accordingly. The aim of the study was to investigate the efficacy of Dr Michaels® (Soratinex®) product line in the treatment of psoriatic patients with different age and disease severity. A total number of 270 patients with verified psoriasis, aged 9-60 years old participated in the studies, including 128 children: 23 girls and 105 boys, (all of them selected from the Department of Dermato-allergology of the Russian Pediatric Hospital Clinic, Moscow, and of the 4th Department of Dermatology of the 52nd Moscow City Hospital Clinic). The patients were separated into 3 groups according to the severity of the disease (based on the PASI-index). All the patients have been treated with Dr Michaels® (Soratinex®) products twice daily, as three different forms were available for application: a cleansing gel, an ointment and a conditioner. The severity of the disease and the efficacy of the treatment have been defined with the evaluation of the PASI index of each patient. The obtained results were recorded in a graphic form showing the changes of the PASI-index on days 3, 7, 14, and 21 counted from the start of the trial. Clinical remission was achieved in 147 patients, a significant improvement in 73, partial improvement in 32, while no effect was seen in 12 patients and deterioration in 6. This open trial demonstrated the clinical efficacy of topical application of Dr Michaels® (Soratinex®) preparation. We observed clinical remissions of psoriasis in adults and in children.

13 Clinical Trial A multi-centred open trial of “Dr Michaels®” (also branded as Soratinex®) topical product family in psoriasis. 2016

Wollina, U / Hercogovấ, J / Fioranelli, M / Gianfaldoni, S / Chokoeva, A A / Tchernev, G / Tirant, M / Novotny, F / Roccia, M G / Maximov, G K / França, K / Lotti, T. ·Department of Dermatology and Allergology, Academic Teaching Hospital Dresden-Friedrichstadt, Dresden, Germany. · 2nd Medical Faculty, Charles University, Bulovka Hospital, Institute of Clinical and Experimental Medicine, Prague, Czech Republic. · Department of Nuclear Physics, Sub-nuclear and Radiation, G. Marconi University, Rome, Italy. · Dermatological Department University of Pisa, Pisa, Italy. · ”Onkoderma”- Policlinic for dermatology and dermatologic surgery, Sofia, Bulgaria; Department of Dermatology and Venereology, Medical University of Plovdiv, Medical faculty, Plovdiv, Bulgaria. · Medical Institute of Ministry of Interior (MVR), Department of Dermatology, Venereology and Dermatologic Surgery, Sofia, Bulgaria. · Psoriasis and Skin Clinic, Melbourne, Australia. · PRO SANUM Ltd., Sanatorium of Prof. Novotný, Štěpánská Prague 1, Czech Republic. · University B.I.S. Group of Institutions, Punjab Technical University, Punjab, India. · Department “Medicinal Information and Non-interventional studies”, Bulgarian Drug Agency, Sofia, Bulgaria. · Department of Dermatology and Cutaneous Surgery, Department of Psychiatry and Behavioral Sciences, Institute for Bioethics and Health Policy, University of Miami, Miller School of Medicine - Miami, FL, USA; Centro Studi per la Ricerca Multidisciplinare e Rigenerativa. Università Degli Studi "G. Marconi", Rome, Italy. · Chair of Dermatology, University of Rome “G. Marconi” Rome, Italy. ·J Biol Regul Homeost Agents · Pubmed #27498651.

ABSTRACT: Psoriasis is a chronic, recurring skin disease affecting 2-4% of the population. Genetic predisposition and precipitating factors play a role in its etiology. The disease can occur in any age or gender group. The most frequently affected areas of the body include scalp, extensor surfaces of the extremities, skin folds and nails. While a number of therapies exist for the treatment of psoriasis with a total resolution of the skin, achieving remission in a high percentage of sufferers, a treatment that results in the maintenance of remission and is free of side effects is still a desirable goal. The aim of the study was to investigate the efficacy and tolerability of Dr Michaels® (Soratinex®) topical product family in psoriasis, in terms of decreasing parakeratosis, inflammation, infiltration and involved area. Seven-hundred-and-twenty-two subjects, mean age 42.3 years (range: 18-68 years) with mild to moderately severe psoriasis, with no other current anti-psoriatic therapy, consisting of 382 males and 340 females, above 18 years of age were included and the observations were subjected to statistical analysis. Triphasic application of Dr Michaels® (Soratinex®) products was employed for 8 weeks, using Cleansing Gel, Scalp and Body Ointment and Skin Conditioner. The treatment proved to be ineffective for 22 patients (3.1%) out of 722. 84 patients (11.6%) had moderate improvement with 26-50% of cleared skin lesions; 102 patients (14.1%) had good improvement with 51-75% of cleared skin lesions; 484 patients (67.0%) experienced outstanding improvement with 76-100% of the cleared skin lesions, with 52% of them achieving total resolution. Twelve patients worsened and discontinued treatment; 18 patients discontinued because of non-compliance; 33 patients developed folliculitis as a side effect. Based on the results of this study, the Dr Michaels® (Soratinex®) product family can be successfully applied in mild to moderately severe psoriasis when considering the exclusion criteria.

14 Article Tuberculosis-related type of psoriasis. 2018

Tsankov, Nikolai / Grozdev, Ivan. ·Dermatology Department, Tokuda Hospital, Sofia, Bulgaria. · Dermatology Department, University Hospital Brugmann, Brussels, Belgium. Electronic address: Ivan.Grozdev@chu-brugmann.be. ·Med Hypotheses · Pubmed #30077192.

ABSTRACT: Psoriasis is a multifaceted disease in terms of its pathophysiological mechanisms, inducing and aggravating factors, clinical types and clinical severity, associated comorbidities and therapeutic modalities. In recent years, an attracting perspective has emerged to identify variants of the disease with their own specific clinical course and management which could stratify the variable spectrum of the disease into different entities (such as palmo-plantar pustulosis). We hypothesize the existence of a unique Tuberculosis-related type of psoriasis that could be managed successfully with rifampicin.

15 Article Apitherapy as a New Approach in Treatment of Palmoplantar Psoriasis. 2018

El-Gammal, Egharid / Nardo, Veronica Di / Daaboul, Farah / Tchernev, Georgi / Wollina, Uwe / Lotti, Jacopo / Lotti, Torello. ·National Research Centre, Doqi, Cairo, Egypt. · Department of Nuclear, Subnuclear and Radiation Physics, University of Rome "G. Marconi", Rome, Italy. · Institute of Dermatological and Regenerative Sciences - Dermatology and Nutrition, Florence, Italy. · Medical Institute of Ministry of Interior (MVR), Department of Dermatology, Venereology and Dermatologic Surgery, Sofia, Bulgaria. · Onkoderma, Policlinic for Dermatology and Dermatologic Surgery, Sofia, Bulgaria. · Städtisches Klinikum Dresden, Department of Dermatology and Allergology, Dresden, Germany. · University "G. Marconi" - Institute of Dermatology, Rome, Italy. ·Open Access Maced J Med Sci · Pubmed #29983801.

ABSTRACT: BACKGROUND: Apitherapy is the medical use of honey bee products, "honey, propolis, royal jelly, bee wax, and bee venom to relieve human ailments. Propolis is one of the most well-documented products derived from the honeybee and has always played an important role in traditional folk medicine. AIM: The aim was to justify the consideration of Aloe Vera as an effective remedy for the treatment of psoriasis. METHODS: The study follows (857) patients (354 females, 503 males) with a mean age range from (9 - 62) years, affected with moderate to severe psoriasis in palms and foot soles treated by a combination mixture of propolis and Aloe in the form of an ointment (Aloreed) and Beauty reed cream. The treatment duration was for 12 weeks. Results were evaluated by using clinical, histological and statistical parameters. RESULTS: After the 12 - week treatment, we observed an 86% overall response rate from which 62% showed excellent results and 24% showed good results, therefore proving the efficiency in the use of the mixture of propolis 50% and aloe vera 3% as topically applied ointment in the treatment of mild to moderate psoriasis. CONCLUSION: Patients who have palmoplantar psoriasis, who were treated with a topically applied mixture of propolis (50%) and aloe vera (3%), have shown noteworthy improvement thus proving the efficiency of propolis and aloe vera in the treatment of mild to moderate psoriasis.

16 Article Therapeutic equivalence of two formulations of calcipotriol-betamethasone ointment: a multicentre, randomized, double-blind study in adult patients with chronic plaque psoriasis. 2018

Habjanic, N / Koytchev, R / Yankova, R / Kerec-Kos, M / Grabnar-Peklar, D. ·Clinical Development, Sandoz Development Center, Lek Pharmaceuticals d.d., Verovškova 57, 1526, Ljubljana, Slovenia. · CCDRD AG, Hoppegarten, Germany. · Diagnostic and Consultation Center 'Sveti Georgi', Plovdiv, Bulgaria. · Chair of Biopharmaceutics and Pharmacokinetics, Faculty of Pharmacy, University of Ljubljana, Ljubljana, Slovenia. ·Br J Dermatol · Pubmed #29945295.

ABSTRACT: -- No abstract --

17 Article Is There a Place for Local Natural Treatment of Psoriasis? 2018

El-Gammal, Agharid / Nardo, Veronica Di / Daaboul, Farah / Tchernev, Georgi / Wollina, Uwe / Lotti, Jacopo / Lotti, Torello. ·Department of Nuclear, Subnuclear and Radiation Physics, University of Rome "G. Marconi", Rome, Italy. · Institute of Dermatological and Regenerative Sciences, Dermatology and Nutrition, Via Alfieri 28, Florence 50121, Italy. · Medical Institute of Ministry of Interior (MVR-Sofia), Department of Dermatology, Venereology and Dermatologic Surgery General Skobelev Nr 79, Sofia 1606, Bulgaria. · Onkoderma - Policlinic for Dermatology and Dermatologic Surgery, General Skobelev 26, Sofia 1407, Bulgaria. · Städtisches Klinikum Dresden, Department of Dermatology and Allergology, Academic Friedrichstrasse 41, Dresden 01067, Germany. · University G. Marconi of Rome, Dept. of Nuclear, Subnuclear and Radiation Physics, Rome, Italy. · Università Degli Studi "G. Marconi", Institute of Dermatology, Rome, Italy. ·Open Access Maced J Med Sci · Pubmed #29875856.

ABSTRACT: BACKGROUND: Apitherapy is the medical use of honey bee products (honey, propolis, royal jelly, bee wax, and bee venom) to relieve human ailments, propolis in particularly, rich in essential oils such as flavonoid. Propolis is derived from tree buds and plants. It is considered as one of the most well-documented products from the honeybee and has always played an important role in traditional folk medicine. Another renowned plant is Aloe vera appertaining to the Liliaceae family. Its mucilaginous gel has been extensively used in many cultures for its apparent effectiveness in treating wounds, burns, itchiness and hair loss. AIM: The aim was to assess the efficacy of a mixture in an ointment form of propolis (50%) and aloe vera (3%), in the treatment of mild to moderate psoriasis. METHODS: In this double-blind control study, 2248 patients with both mild to moderate cases of psoriasis were evaluated from 2012 to 2015. RESULTS: In Group 1 the overall response at the end of 12 weeks was as follows: Cleared in 64.4% (excellent response), good response in 22.2%, and weak response in 5.6% and no response in 7.7%. In Group 2 (placebo group) no significant improvement was observed after 12 weeks of treatment. Also, histology also demonstrated a marked reduction in hyperkeratosis and acanthosis. CONCLUSION: In comparison with Group 2 (placebo group) patients in Group 1, treated with a mixture of propolis (50%) and aloe vera (3%), in the form of an ointment have shown noteworthy improvement thus substantiating the therapeutic value of propolis and aloe vera in the treatment of mild to moderate psoriasis.

18 Article Implementation of Instrument Based on Eight Health Related Quality of Life Domains for Measuring of Willingness to Pay for Psoriasis Treatment. 2017

Dobrev, Hristo P / Atanasov, Nikolay G / Dimitrova, Donka D. ·Department of Dermatology and Venereology, Faculty of Medicine, Medical University of Plovdiv, Plovdiv, Bulgaria · Department of Health Management and Health Economics, Faculty of Public Health, Medical University of Plovdiv, Plovdiv, Bulgaria ·Folia Med (Plovdiv) · Pubmed #28976906.

ABSTRACT: BACKGROUND: Psoriasis vulgaris (PsV) is a chronic skin condition that has a major impact on health-related quality of life (HRQOL). AIM: To determine the individual burden of PsV on HRQOL using willingness to pay (WTP) instrument. MATERIALS AND METHODS: Fifty-one consecutive PsV patients were asked to evaluate their overall health and psoriasis affected health by visual analogue scale (VAS), and interviewed on 8 domains (physical, emotional, sleep, work, social, self-care, intimacy, and concentration) of HRQOL and WTP for a hypothetical cure in each domain. Two additional questions proposing 6 alternatives for therapy were also asked. The analysis is performed with descriptive and frequency statistics, Mann-Whitney and Kruskal-Wallis tests. RESULTS: The domains ranked highly were: physical comfort (90%), social comfort (77%), emotional health (75%) and work (53%). The following tendencies concerning WTP for top four impacted domains were found: the median WTP were the highest in the top impacted domains; the younger patients were willing to pay more than the older ones; the highest median WTP amounts appear in the lowest income group; the highest median WTP is associated with smaller psoriasis affected health VAS scores. The largest proportion and number of patients (37.3%, n=19) stated preferences for the systemic therapy. The second preferred choice was the thalassotherapy (29.4%, n=15). CONCLUSIONS: The utility and reliability of the instrument based on the assessment of WTP stated preferences for 8 domains of HRQOL for evaluation the individual burden of psoriasis were strongly supported.

19 Article Cutaneous and visceral leishmaniasis during anti-TNFα therapy. 2017

Guarneri, Claudio / Bevelacqua, Valentina / Patterson, James W / Tchernev, Georgi. ·Department of Clinical Experimental Medicine, Unit of Dermatology, University of Messina, C/O A.O.U. "G. Martino", via Consolare Valeria 1, 98125, Messina, Italy. · Unit of Dermatology at A.O.R.N.A.S. "G. Garibaldi" and Department of General Pathology, University of Catania, Piazza Santa Maria del Gesù, 95125, Catania, Italy. · Department of Pathology, Department of Dermatology, University of Virginia Health System, 1215 Lee Street, Box 800214, 22908, Charlottesville, VA, USA. · Department of Dermatology, Venereology and Dermatologic Surgery, Medical Institute of Ministry of Interior (MVR), General Skobelev blvd. 79, 1606, Sofia, Bulgaria. georgi_tchernev@yahoo.de. ·Wien Med Wochenschr · Pubmed #27832423.

ABSTRACT: The long-term use of novel antipsoriatic systemic biotechnological drugs may increase susceptibility to opportunistic infections. Several cases of visceral leishmaniasis have been reported in immunosuppressed individuals, including those who have been treated with tumour necrosis factor alpha (TNFα) blocking agents. Simultaneous occurrence of cutaneous and visceral involvement has been more rarely recorded in the medical literature. Herein, we describe a case of mucosal leishmaniasis occurring in a farmer living in an endemic region, who was treated with golimumab because of psoriatic arthritis. This highlights the importance of recognizing cutaneous lesions as a first indicator of possible underlying kala-azar disease.

20 Article Rapid communication: a vegetable oil extract restores redox status in fibroblasts from psoriatic patients. 2016

Barygina, V / Becatti, M / Mannucci, A / Taddei, N / Tirant, M / Hercogovấ, J / França, K / Fioranelli, M / Roccia, M G / Tchernev, G / Wollina, U / Lotti, T / Fiorillo, C. ·Department of Experimental and Clinical Biomedical Sciences, University of Florence, Florence Italy. · Psoriasis and Skin Clinic, Melbourne, Australia. · 2nd Medical Faculty, Charles University, Bulovka Hospital, Institute of Clinical and Experimental Medicine, Prague, Czech Republic. · Department of Dermatology and Cutaneous Surgery,
Department of Psychiatry and Behavioral Sciences,
Institute for Bioethics and Health Policy,
University of Miami, Miller School of Medicine, Miami, FL, USA. · Department of Nuclear Physics, Sub-nuclear and Radiation, G. Marconi University, Rome, Italy. · University B.I.S. Group of Institutions, Punjab Technical University, Punjab, India. · Medical Institute of Ministry of Interior (MVR), Department of Dermatology, Venereology and Dermatologic Surgery, Sofia, Bulgaria. · Department of Dermatology and Allergology, Academic Teaching Hospital Dresden-Friedrichstadt, Dresden, Germany. · Chair of Dermatology, University of Rome “G. Marconi” Rome, Italy. ·J Biol Regul Homeost Agents · Pubmed #27498670.

ABSTRACT: Psoriasis is an inflammatory skin disease that affects 2-5% of the worldwide population. It is a chronic immune-mediated hyperproliferative inflammatory skin disease of unknown etiology, characterized by the appearance of sore patches of thick, red skin with silvery scales.

21 Article Dr Michaels® product family (also branded as Soratinex®) versus Methylprednisolone aceponate - a comparative study of the effectiveness for the treatment of plaque psoriasis. 2016

Hercogovấ, J / Fioranelli, M / Gianfaldoni, S / Chokoeva, A A / Tchernev, G / Wollina, U / Tirant, M / Novotny, F / Roccia, M G / Maximov, G K / França, K / Lotti, T. ·2nd Medical Faculty, Charles University, Bulovka Hospital, Institute of Clinical and Experimental Medicine, Prague, Czech Republic. · Department of Nuclear Physics, Sub-nuclear and Radiation, G. Marconi University, Rome, Italy. · Dermatological Department University of Pisa, Pisa, Italy. · ”Onkoderma”-Policlinic for dermatology and dermatologic surgery, Sofia, Bulgaria; Department of Dermatology and Venereology, Medical University of Plovdiv, Medical faculty, Plovdiv, Bulgaria. · Medical Institute of Ministry of Interior (MVR), Department of Dermatology, Venereology and Dermatologic Surgery, Sofia, Bulgaria. · Department of Dermatology and Allergology, Academic Teaching Hospital Dresden-Friedrichstadt, Dresden, Germany. · Psoriasis and Skin Clinic, Melbourne, Australia. · PRO SANUM Ltd., Sanatorium of Prof. Novotný, Štěpánská Prague 1, Czech Republic. · University B.I.S. Group of Institutions, Punjab Technical University, Punjab, India. · Department “Medicinal Information and Non-interventional studies”, Bulgarian Drug Agency, Sofia, Bulgaria. · Department of Dermatology and Cutaneous Surgery, Department of Psychiatry and Behavioral Sciences, Institute for Bioethics and Health Policy, University of Miami, Miller School of Medicine, Miami, FL, USA; Centro Studi per la Ricerca Multidisciplinare e Rigenerativa, Università Degli Studi "G. Marconi", Rome, Italy. · Chair of Dermatology, University of Rome “G. Marconi” Rome, Italy. ·J Biol Regul Homeost Agents · Pubmed #27498662.

ABSTRACT: As one of the most common dermatologic chronic-recurrent disease, variable therapeutic options are available today for management of psoriasis. Although topical high potency corticosteroids, alone or in association with salicylic acid or vitamin D analogues, are still considered the best treatment, they do not seem to possess the capability for a long-term control of the disease or prevent recurrences, as their side effects are major contraindications for continuative use. The aim of this study was to investigate whether Dr. Michaels® product family is comparable to methylprednisolone aceponate (MPA) as a viable alternative treatment option for the treatment and management of stable chronic plaque psoriasis. Thirty adults (13 male, 17 female, mean age 40 years) with mild to severe stable chronic plaque psoriasis, were included in the study. Patients were advised to treat the lesions of the two sides of their body (left and right) with two different unknown modalities for 8 weeks; the pack of Dr. Michaels® products on the left side (consisting of a cleansing gel, an ointment and a skin conditioner) and a placebo pack on the right side, consisting of a cleansing gel, methylprednisolone ointment and a placebo conditioner. Assessment was done using the Psoriasis Activity Severity Index (PASI) scores before treatment and after 2, 4, 6 and 8 weeks. The results achieved with the Dr. Michaels® (Soratinex®) product family for the treatment of chronic plaque psoriasis were better than the results achieved with methylprednisolone aceponate (MPA), even though quicker resolution was achieved with the steroid with 45% of patients achieving resolution within 8-10 days in comparison to 5-6 weeks in the Dr. Michaels® (Soratinex®) group. Before therapy, the mean PASI score of the LHS in Dr. Michaels® (Soratinex®) group was 13.8±4.1 SD and 14.2±4.2 SD in the RHS methylprednisolone aceponate (MPA) group. After 8 weeks of treatment 62% of the Dr. Michaels® (Soratinex®) group had achieved resolution whilst in the methylprednisolone aceponate (MPA) group, the figure remained at 45%. The mean PASI score after 8 weeks of treatment was calculated and in the LHS Dr. Michaels® (Soratinex®) group it was 2.8±1.6 SD and 6.8±2.4 SD in the RHS methylprednisolone aceponate group. In the RHS -methylprednisolone aceponate (MPA) group, 22% of patients failed to respond to the treatment in comparison to 6% in the LHS Dr. Michaels® (Soratinex®) group. Based on the results of this study, Dr. Michaels® products are a more effective treatment option, with insignificant side effects, compared to local treatment with methylprednisolone aceponate (MPA).

22 Article Investigation of the efficacy of Dr Michaels® (Soratinex®) family in maintaining a symptom-free state for patients with psoriasis in remission. A retrospective, comparative study. 2016

Hercogovấ, J / Fioranelli, M / Gianfaldoni, S / Chokoeva, A A / Tchernev, G / Wollina, U / Tirant, M / Novotny, F / Roccia, M G / Maximov, G K / França, K / Lotti, T. ·2nd Medical Faculty, Charles University, Bulovka Hospital, Institute of Clinical and Experimental Medicine, Prague, Czech Republic. · Department of Nuclear Physics, Sub-nuclear and Radiation, G. Marconi University, Rome, Italy. · Dermatological Department University of Pisa, Pisa, Italy. · ”Onkoderma”-Policlinic for dermatology and dermatologic surgery, Sofia, Bulgaria; Department of Dermatology and Venereology, Medical University of Plovdiv, Medical faculty, Plovdiv, Bulgaria. · Medical Institute of Ministry of Interior (MVR), Department of Dermatology, Venereology and Dermatologic Surgery, Sofia, Bulgaria. · Department of Dermatology and Allergology, Academic Teaching Hospital Dresden-Friedrichstadt, Dresden, Germany. · Psoriasis and Skin Clinic, Melbourne, Australia. · PRO SANUM Ltd, Sanatorium of Prof. Novotný, Štěpánská Prague 1, Czech Republic. · University B.I.S. Group of Institutions, Punjab Technical University, Punjab, India. · Department “Medicinal Information and Non-interventional studies”, Bulgarian Drug Agency, Sofia, Bulgaria. · Department of Dermatology and Cutaneous Surgery, Department of Psychiatry and Behavioral Sciences, Institute for Bioethics and Health Policy, University of Miami, Miller School of Medicine, Miami, FL, USA; Centro Studi per la Ricerca Multidisciplinare e Rigenerativa, Università Degli Studi "G. Marconi", Rome, Italyi. · Chair of Dermatology, University of Rome “G. Marconi” Rome, Italy. ·J Biol Regul Homeost Agents · Pubmed #27498661.

ABSTRACT: Psoriasis is a chronic inflammatory disease, affecting about 3% of the worldwide population. Although there are many therapeutic options available today for psoriasis, none of them can be considered as the gold standard treatment for maintaining a sustained period of remission. The aim of this study was to investigate whether a maintenance dosage of Michaels® Soratinex® product family is effective in maintaining a symptom-free state for patients in remission. Fifty patients (23 male, 27 female), aged 18-58-years-old (mean age: 38.3), affected by mild to severe plaque psoriasis (mean duration: 29.5), were included in this retrospective study. All of them had completed previous treatment and achieved remission. Twenty-eight had been previously treated with an Australian series of herbal skin-care products (Dr. Michaels® Soratinex® skincare products for psoriasis) and 22 treated with biologics. We evaluated the clinical condition of the member of each group every 4 weeks, for 16 times following remission. Maintenance group continued treatment with Dr Michaels® (Soratinex®). Non-Maintenance group discontinued both forms of treatment. The evaluation was based on the PASI score, assuming that at baseline it was zero. Out of 34 patients who continued treatment with Dr Michaels® (Soratinex®) product family in the Maintenance group (22 previously treated with Dr Michaels and 12 previously treated with Biologic), 26 remained symptom free with baseline PASI of zero. Six patients had a mild flare with a PASI increase of 0-25%. Two patients were in the moderate group with a PASI increase of 26-50% and were initially treated with biologic. Out of 6 patients in Dr Michaels non-maintenance group, 3 patients remained symptom free, 1 had a rebound starting on week 36 and 2 rebounded at week 44. Out of 10 patients who were in the non-maintenance from the biologic group, 6 rebounded at week 12, 2 rebounded at week 16, 1 rebounded at week 24 and 1 rebounded at week 32. In the maintenance group no side effects were described, except for a mild form of folliculitis in 3 patients. Treatment did not have to be discontinued and all 3 patients cleared. Based on the results of this study, Dr. Michaels® (Soratinex®) product family can be safely and successfully applied to maintain a symptom-free state, after patients go into remission following treatment with Dr. Michaels® (Soratinex®) product family or biologics in mild to very severe psoriasis, when considering the exclusion criteria.

23 Article Nail psoriasis in an adult successfully treated with a series of herbal skin care products family – a case report. 2016

Tirant, M / Hercogovấ, J / Fioranelli, M / Gianfaldoni, S / Chokoeva, A A / Tchernev, G / Wollina, U / Novotny, F / Roccia, M G / Maximov, G K / França, K / Lotti, T. ·Psoriasis and Skin Clinic, Melbourne, Australia. · 2nd Medical Faculty, Charles University, Bulovka Hospital, Institute of Clinical and Experimental Medicine, Prague, Czech Republic. · Department of Nuclear Physics, Sub-nuclear and Radiation, G. Marconi University, Rome, Italy. · Dermatological Department University of Pisa, Pisa, Italy. · ”Onkoderma”- Policlinic for dermatology and dermatologic surgery, Sofia, Bulgaria; Department of Dermatology and Venereology, Medical University of Plovdiv, Medical faculty, Plovdiv, Bulgaria. · Medical Institute of Ministry of Interior (MVR), Department of Dermatology, Venereology and Dermatologic Surgery, Sofia, Bulgaria. · Department of Dermatology and Allergology, Academic Teaching Hospital Dresden-Friedrichstadt, Dresden, Germany. · PRO SANUM Ltd., Sanatorium of Prof. Novotný, Štěpánská Prague 1, Czech Republic. · University B.I.S. Group of Institutions, Punjab Technical University, Punjab, India. · Department “Medicinal Information and Non-interventional studies”, Bulgarian Drug Agency, Sofia, Bulgaria. · Department of Dermatology and Cutaneous Surgery, Department of Psychiatry and Behavioral Sciences, Institute for Bioethics and Health Policy, University of Miami, Miller School of Medicine - Miami, FL, USA; Centro Studi per la Ricerca Multidisciplinare e Rigenerativa. Università Degli Studi "G. Marconi", Rome, Italy. · Chair of Dermatology, University of Rome “G. Marconi” Rome, Italy. ·J Biol Regul Homeost Agents · Pubmed #27498654.

ABSTRACT: Psoriasis is a common chronic inflammatory dermatosis that causes significant distress and morbidity. Approximately 50% of patients with cutaneous psoriasis and 90% of patients with psoriatic arthritis demonstrate nail involvement of their psoriasis. Left untreated, nail psoriasis may progress to debilitating nail disease that leads to not only impairment of function but also on quality of life. We report the case of a 50-year-old male patient with recalcitrant nail dystrophies on the fingers since the age of 40, who responded successfully to Dr. Michaels® product family. The patient had a 35-year history of plaque psoriasis localised on the scalp, ears, groin, limbs, and trunk and with psoriatic arthritis. The nail symptoms consisted of onycholysis, onychomycosis, leukonychia, transverse grooves, nail plate crumbling and paronychia of the periungal skin. This case represents the efficacy and safety of the Dr. Michaels® (Soratinex® and Nailinex®) product family with successful resolution of nail dystrophies and surrounding paronychia with no reported adverse events.

24 Article A European prospective, randomized placebo-controlled doubleblind Study on the efficacy and safety of Dr Michaels® (also branded as Soratinex®) product family for stable chronic plaque psoriasis. 2016

França, K / Hercogovấ, J / Fioranelli, M / Gianfaldoni, S / Chokoeva, A A / Tchernev, G / Wollina, U / Tirant, M / Novotny, F / Roccia, M G / Maximov, G K / Lotti, T. ·Department of Dermatology and Cutaneous Surgery, Department of Psychiatry and Behavioral Sciences, Institute for Bioethics and Health Policy, University of Miami, Miller School of Medicine - Miami, FL, USA; Centro Studi per la Ricerca Multidisciplinare e Rigenerativa. Università Degli Studi "G. Marconi", Rome, Italy. · 2nd Medical Faculty, Charles University, Bulovka Hospital, Institute of Clinical and Experimental Medicine, Prague, Czech Republic. · Department of Nuclear Physics, Sub-nuclear and Radiation, G. Marconi University, Rome, Italy. · Dermatological Department, University of Pisa, Pisa, Italy. · ”Onkoderma”- Policlinic for dermatology and dermatologic surgery, Sofia, Bulgaria; Department of Dermatology and Venereology, Medical University of Plovdiv, Medical faculty, Plovdiv, Bulgaria. · Medical Institute of Ministry of Interior (MVR), Department of Dermatology, Venereology and Dermatologic Surgery, Sofia, Bulgaria. · Department of Dermatology and Allergology, Academic Teaching Hospital Dresden-Friedrichstadt, Dresden, Germany. · Psoriasis and Skin Clinic, Melbourne, Australia. · PRO SANUM Ltd., Sanatorium of Prof. Novotný, Štěpánská Prague 1,Czech Republic. · University B.I.S. Group of Institutions, Punjab Technical University, Punjab, India. · Department “Medicinal Information and Non-interventional studies”, Bulgarian Drug Agency Sofia, Bulgaria. · Chair of Dermatology, University of Rome “G. Marconi” Rome, Italy. ·J Biol Regul Homeost Agents · Pubmed #27498652.

ABSTRACT: Psoriasis is a chronic, inflammatory, recurrent, genetically determined dermatitis that affects the skin and joints. Many patients affected by this condition seek alternatives and complementary treatment options such as herbal medicines. In order to establish the safety of these products, trials, according to medical standards should be performed to provide the highest quality of data. The aim of this study was to assess the efficacy and safety of an Australian series of herbal skincare products [Dr. Michaels® (Soratinex®) skin-care products for psoriasis] for the management of stable chronic plaque psoriasis. We studied 142 patients (68 females and 74 males) with mild to moderate, stable, chronic plaque psoriasis and they were randomly assigned to either verum or control group. Exclusion criteria were: severe psoriasis, arthropathic psoriasis, intertriginous psoriasis, palmoplantar psoriasis, use of any antipsoriatic treatment and any medication which could influence or interfere with the course of the disease. Both groups consisted of a cleansing gel, an ointment and an oil blend (skin conditioner), packed in neutral bottles, used twice daily for all lesions except the scalp, for 8 weeks. As control products, we used compositions of well-known neutral ointments and medicinal bathing oil. Assessment, using the Psoriasis Activity Severity Index (PASI) scores, was done before treatment and after 2, 4, 6 and 8 weeks. Patient improvement was determined by the percentage reduction of the PASI scores. Statistical analysis was carried out using the Mann-Whitney-U Test with SPSS for Windows. Our investigation demonstrates that complementary methods can play a role in dermatologic therapy as long as they undergo standardised clinical trials and fulfil the basic requirements such as product safety and quality assurance. This study shows that Dr Michaels (Soratinex®) herbal skin-care products improve mild to moderate stable chronic plaque psoriasis significantly.

25 Article Polyamine metabolism changes in psoriasis. 2013

Broshtilova, Valentina / Lozanov, Valentina / Miteva, Ljubka. ·Departments of Dermatology and Venereology, Faculty of Medicine, Sofia Medical University, Bulgaria. ·Indian J Dermatol · Pubmed #23919004.

ABSTRACT: INTRODUCTION: Polyamines - putrescine, spermidine and spermine are polycationic compounds ubiquitous for all living organisms. They are essential for the cell growth and differentiation, the control of cell cycle progress, apoptosis, and cancerogenesis. Accumulated scientific evidence suggests the central role of polyamines in the process of keratinocytic proliferation, differentiation, and regulation. OBJECTIVE: To elucidate the polyamine metabolic changes that occur in benign keratinocytic proliferation. Fifty eight patients were enrolled in the study, 31 with plaque-form of psoriasis vulgaris, which had been referred to as a model of benign keratinocytic proliferation, and 27-healthy controls. MATERIALS AND METHODS: An original, innovative chromatographic method was used to detect the levels of putrescine, spermidine, and spermine in all skin samples. RESULTS: Were significantly proven (P < 0.05). No difference was found between the polyamines levels of non-lesional psoriatic skin and healthy controls. Psoriatic lesions showed a two-time higher concentration of all polyamines in lesional, compared to non-lesional skin. Spermine had the highest concentration and highest proliferation trend, which demonstrated the importance of propylamine synthesis in the pathogenesis of psoriasis. Spermine highest concentrations suggested the leading role of adenosine methionine decarboxylase (AMDC) in the pathogenesis of benign keratinocytic proliferations. CONCLUSIONS: Non-lesional skin in psoriatic patients did not show latent changes in polyamine metabolism. Psoriatic lesions demontrated two-time higher levels of the most essential biogenic polyamines compared to healthy controls. The highest level of spermine proved the crucial role of AMDC in the polyamine metabolism changes in psoriasis. Future therapeutic approaches should be focused on reduction of exogenic spermine intake, utilizing new spermine blockers, and synthesis of AMDC inhibitors.

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