EFFICACY AND SAFETY OF DR MICHAELS® (SORATINEX®) PRODUCT FAMILY FOR THE TOPICAL TREATMENT OF PSORIASIS: A MONITORED STATUS STUDY
K. FRANÇA1,13, F. NOVOTNY2, J. HERCOGOVẤ3,4, M. FIORANELLI5, S.GIANFALDONI6, A.A. CHOKOEVA7,8, G. TCHERNEV9, U. WOLLINA10, M. TIRANT11,
M.G. ROCCIA12 and T. LOTTI14
1Department of Dermatology & Cutaneous Surgery Department of Psychiatry & Behavioral Sciences, Institute for Bioethics & Health Policy, University of Miami, Miller School of Medicine, Miami, FL, USA; 2PRO SANUM Ltd, Sanatorium of Prof. Novotný, Štěpánská Prague 1, Czech Republic; 32nd Medical Faculty, Charles University, Bulovka Hospital, 4Institute of Clinical and Experimental Medicine, Prague, Czech Republic; 5Department of Nuclear Physics, Sub-nuclear and Radiation, Guglielmo Marconi University, Rome, Italy; 6Dermatological Department University of Pisa, Pisa, Italy; 7”Onkoderma”-Policlinic for dermatology and dermatologic surgery, Sofia, Bulgaria; 8Department of Dermatology and Venereology, Medical University of Plovdiv, Medical faculty, Plovdiv, Bulgaria; 9Medical Institute of Ministry of Interior (MVR), Department of Dermatology, Venereology and Dermatologic Surgery, Sofia, Bulgaria; 10Department of Dermatology and Allergology, Academic Teaching Hospital Dresden-Friedrichstadt, Dresden, Germany; 11Psoriasis & Skin Clinic, Melbourne, Australia; 12University B.I.S. Group of Institutions, Punjab Technical University, Punjab, India; 13Centro Studi per la Ricerca Multidisciplinare e Rigenerativa, Università Degli Studi “G. Marconi”, Rome, Italy; 14Chair of Dermatology, University of Rome “G. Marconi” Rome, Italy
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. 75 (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.