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Clinical Trials

At Psoriasis Eczema Clinic we believe strongly in following the scientific method to ensure our treatment protocols are as effective as possible. The following papers details the clinical trials on effective psoriasis treatment protocols and case studies that have been conducted both in Australia and overseas.

2016

journal-biological-regulators JOURNAL OF BIOLOGICAL REGULATORS & HOMEOSTATIC AGENTS

Volume 30, No. 2 (Supplement 3), April – June, 2016 CONTENTS 1 9 15 21 29 35 43 49 55 65 73 77 83 89 95 103 109 115 121 129

U. Wollina, J. Hercogova, M. Fioranelli, S. Gianfaldoni, A.A. Chokoeva, G. Tchernev, M. Tirant, F. Novotny, M.G. Roccia, G.K. Maximov, K. França and T. Lotti. A multi-centred open trial of “Dr Michaels®” (also branded as Soratinex®) topical product family in psoriasis

K. França, J. Hercogova, M. Fioranelli, S. Gianfaldoni, A.A. Chokoeva, G. Tchernev, U. Wollina, M. Tirant, F. Novotny, M.G. Roccia, G.K. Maximov and T. Lotti. A European prospective, randomized placebo-controlled double-blind study on the efficacy and safety of Dr Michaels® (also branded as Soratinex®) product family for stable chronic plaque psoriasis 

J. Hercogova, M. Fioranelli, S. Gianfaldoni, A.A. Chokoeva, G. Tchernev, U. Wollina, M. Tirant, F. Novotny, M.G. Roccia, G.K. Maximov, K. França and T. Lotti. A clinical examination of the efficacy of preparation of Dr Michaels® (also branded as Soratinex®) products in the treatment of asis 

M. Tirant, J. Hercogova, M. Fioranelli, S. Gianfaldoni, A.A. Chokoeva, G. Tchernev, U. Wollina, F. Novotny, M.G. Roccia, G.K. Maximov, K. França and T. Lotti. Nail psoriasis in an adult successfully treated with a series of herbal skin care products family – a case report 

M. Fioranelli, J. Hercogova, S. Gianfaldoni, A.A.Chokoeva, G. Tchernev, U. Wollina, M Tirant, F. Novotny, M.G. Roccia, G.K. Maximov, K. França and T. Lotti. Clinical evaluation of the effectiveness of “Dr Michaels®” (also branded as Soratinex®) products in the topical treatment of patients with plaque psoriasis

M. Tirant, P. Anderson, P. Bayer, J. Hercogova, M. Fioranelli, S. Gianfaldoni, A.A. Chokoeva, G. Tchernev, U. Wollina, F. Novotny, M.G. Roccia, G.K. Maximov, K. França and T. Lotti. Successful treatment of a chronic eczema in a 48-year-old female with Dr Michaels® (Eczitinex® and Itchinex®) product family. a case report 

J. Hercogova, M. Fioranelli, S.Gianfaldoni, A.A. Chokoeva, G. Tchernev, U. Wollina, M Tirant, F.Novotny, M.G.Roccia, G.K. Maximov, K. França and T. Lotti. Dr Michaels® (Soratinex®) product for the topical treatment of psoriasis: a Hungarian/Czech and Slovak study

U. Wollina, M. Tirant, P. Bayer, M. Coburn, M. Smith, B. Donnelly, T. Kennedy, J. Gaibor, M. Arora, L. Clews, S. Walsley, J. Hercogov?, M. Fioranelli, S. Gianfaldoni, A.A. Chokoeva, G. Tchernev, F.Novotny, M.G. Roccia, G.K. Maximov, K. França and T. Lotti. Successful treatment of mild to moderate acne vulgaris with Dr Michaels® (also branded as Zitinex®) topical products family: a clinical trial 

K. França, J. Hercogova, M. Fioranelli, S. Gianfaldoni, A.A. Chokoeva, G. Tchernev, U. Wollina, M. Tirant, P. Bayer, M. Coburn, M. Smith, B. Donnelly, T. Kennedy, J. Gaibor, M. Arora, L. Clews, F. Novotny, M.G. Roccia, G.K. Maximov and T. Lotti. Investigation of the efficacy and tolerability of Dr Michaels® (also branded as Eczitinex® and Itchinex) topical products in the treatment of atopic dermatitis in children 

M. Tirant, P. Bayer, J. Hercogova, M. Fioranelli, S.Gianfaldoni, A.A.Chokoeva, G. Tchernev, U. Wollina, F. Novotny, M.G. Roccia, G.K. Maximov, K. França and T. Lotti. Treatment of ichthyosis lamellaris using a series of herbal skin care products family 

J. Hercogova, M. Fioranelli, S. Gianfaldoni, A.A. Chokoeva, G. Tchernev, U. Wollina, M. Tirant, F. Novotny, M.G. Roccia, G.K. Maximov, K. França and T. Lotti. 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 

J. Hercogova, M. Fioranelli, S. Gianfaldoni, A.A. Chokoeva, G. Tchernev, U. Wollina, M Tirant, F.Novotny, M.G.Roccia, G.K. Maximov, K. França, and T. Lotti. Dr Michaels® product family (also branded as Soratinex®) versus methylprednisolone aceponate – a comparative study of the effectiveness for the treatment of plaque psoriasis 

U. Wollina, J. Hercogova, M. Fioranelli, S.Gianfaldoni, A.A. Chokoeva, G. Tchernev, M. Tirant, F.Novotny, M.G. Roccia, G.K. Maximov, K. França and T. Lotti. Successful treatment of alopecia areata with Dr. Michaels® product family ..

J. Hercogova, M. Tirant, P. Bayer, M. Coburn, B. Donnelly, T. Kennedy, J. Gaibor, M. Arora, L. Clews, M. Fioranelli, S. Gianfaldoni, A.A. Chokoeva, G. Tchernev, U.Wollina, F. Novotny, M.G. Roccia, G.K. Maximov, K. França and T. Lotti. Successful treatment of recalcitrant candidal intertrigo with Dr Michaels® (Fungatinex®) product family

M. Tirant, P. Bayer, J. Hercogova, M. Fioranelli, S. Gianfaldoni, A.A. Chokoeva, G. Tchernev, U. Wollina, F. Novotny, M.G.Roccia, G.K. Maximov, K. França and T. Lotti. Successful treatment of facial systemic lupus erythematosus lesions with Dr Michaels® (Soratinex®) product family. A case report U. Wollina, J. Hercogov?, M. Fioranelli, S. Gianfaldoni, A.A. Chokoeva, G. Tchernev, M. Tirant, F. Novotny, M.G. Roccia, G.K. Maximov, K. França and T. Lotti. Scalp psoriasis: a promising natural treatment 

S. Gianfaldoni, J. Hercogova, M. Fioranelli, A.A. Chokoeva, G. Tchernev, U.Wollina, M. Tirant, F. Novotny, M.G. Roccia, G.K. Maximov, K. França and T. Lotti. An innovative, promising topical treatment for psoriasis: a Romanian clinical study 

K. França, F. Novotny, J. Hercogova, M. Fioranelli, S.Gianfaldoni, A.A. Chokoeva, G. Tchernev, U. Wollina, M. Tirant, M.G. Roccia and T. Lotti. Efficacy and safety of Dr Michaels® (Soratinex®) product family for the topical treatment of psoriasis: a monitored status study 

K. França, M. Tirant, J. Hercogova, F. Novotny, M. Fioranelli, S. Gianfaldoni, A.A.Chokoeva, G. Tchernev, U.Wollina, M.G. Roccia and T. Lotti. Quality of life aspects of patients with psoriasis using a series of herbal products 

V. Barygina, M. Becatti, A. Mannucci, N. Taddei, M. Tirant, J. Hercogova, K. França, M. Fioranelli, M.G. Roccia, G. Tchernev, U. Wollina, T. Lotti and C. Fiorillo. Short Comunication: a vegetable oil extract restores redox status in fibroblasts from psoriatic patients

2000 – 2010

Trial Country Conducted by
Report of the Study of the “Dr. Michaels” Topical Product Family in Psoriasis Australia Dr. Thomas Smith – Monash University
Prospective, Randomised Placebo-Controlled Double-Blind Study – Chronic Plaque Psoriasis, Journal of the European Academy of Dermatology and Venereology Austria Prof. H. Maier – Department of Dermatology, Medical University of Vienna, Vienna, Austria.
New Complementary Treatment for Psoriasis Romania/ Hungary Dept. of Dermato-Venereology, Semmelweis University, and Dept. of Dermatology, KOLOZSVAR – ROMANIA.
Dr. Michaels’ topical product family in psoriasis Hungary Prof. Dr. Attila Horvath – Dept. of Dermato-Venereology, Semmelweis University.
Clinical Examination of the Efficacy of Preparations Dr. Michael in the Treatment of Cases of Psoriasis with Deferring Severity Russia Prof. N.G. Korotky – Head of the Department of Dermatology and Venereology of the Paediatric Clinic at the Russian State Medical University.
The Results Of Attestation Study Of Effectiveness – Dr. Michaels Psoriasis Products (undertaken during the years 2005-2008) Czech Rep. Head Physician MUDr. Štepánka Capková, Faculty Hospital Motol. MUDr. Michaela Havlícková, Faculty Hospital Královské Vinohrady. Prof. MUDr. Karel Pizinger, Faculty Hospital in Plzen. Head Physician MUDr. Jaroslav Hoffmann, Central Military Hospital in Praha. Doc. MUDr. Karel Ettler, CSc. Faculty Hospital in Hradec Králové. Head Physician MUDr. Hana Duchková, DrSc. Dermatology Sanatorium in Ústí nadLabem. Head Physician MUDr. Hana Bucková, Ph.D. Faculty Hospital in Brno. Head Physician MUDr. Hana Zelenková, Ph.D. DOST – Svidník, Slovensko(Slovakia). Prof. MUDr. František Novotný, DrSc. Prague Dermatology Center. Prof. MUDr. Jana Hercogová, CSc. Faculty Hospital Bulovka.
Study about efficacy of Dr.Michaels pharmaceuticals in psoriasis in sanitorium of Prof. Novotný. Czech Rep. Prof. MUDr. František Novotný, DrSc. Prague Dermatology Center. 
To investigate whether Dr. Michaels product family is comparable to Advantan – methylprednisolone aceponate (MPA) as a viable alternative treatment option for the treatment and management of Stable Chronic Plaque Psoriasis. Comparative Study – 2009  China Professor Lee Feng – Head of the Department of Dermatology and Venereology, Southern Medical University (Guang Dong).

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Australian Trial
Report of the study of the “Dr Michaels” topical product family in psoriasis. (Australian Trial)

PDF: AustralianTrial.pdf

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Austrian Trial
“Prospective, randomized placebo-controlled double-blind study on the efficacy and safety of a series of herbal skin-care products for stable chronic plaque psoriasis.”

Dermatology, Medical University of Vienna, Vienna, Austria, Dermatology, Psoriasis & Skin Clinic, Melbourne, Australia, and was published in the Journal of the European Academy of Dermatology and Venereology, Volume 18. Number 6, November 2004. P061.

Background: Among patients with psoriasis concern is growing about possible side effects of long-term steroid therapy and more and more of them turn to complementary treatment options.

PDF: AustrianTrial.pdf

Czech Republic Trial
Study about Efficacy of Dr Michaels Pharmaceuticals in Psoriasis in Sanatorium of Prof. Novotný in Prague.
“The goal of the study was verification of the efficacy of Dr Michaels remedies in selected patients suffering from psoriasis…..The comparative tests have monitored status and therapy before Dr Michaels treatment. This fact is described in 10 patients under review….We evaluate the results of therapy by Dr Michaels remedies on average on 90% namely not only in 10 cases monitored in the study, but in additional 65 cases treated in our clinic by these remedies…” Prof. Novotný.

PDF: CzechTrial.pdf

Hungarian Trial
“Evaluation of the Dr Michaels topical product family in psoriasis, to determine its efficacy, adverse effects and tolerability.”
“Based on the results of this study, the Dr Michaels product family can be successfully applied in mild to moderately severe psoriasis.”

PDF: HungarianTrial.pdf

Polish Trial

“These preparations due to the simultaneous operation of oiling and moisturizing, the absence, in most cases, the occurrence of side effects, can be used for a long time and recommended for long-term care of the skin in patients with psoriasis.”

PDF: PolishTrial.pdf

Romanian Trial
“Trials were conducted at Department of Dermatology, SEMMELWEIS UNIVERSITY, BUDAPEST and at Department of Dermatology, KOLOZSVAR, ROMANIA”

“95% of the patients stated that they would continue to use the product due to it’s effectiveness, including those who had only moderate improvement.”

PDF: RomaniaTrial.pdf

Russian Trial
Clinical examination of the efficacy of preparation Dr Michael topicals in the treatment of cases of psoriasis with differing severity.

“This treatment method is highly effective and, in terms of efficacy, it is comparable to the generally used therapeutic regimen which is based on the application steroid ointments with fluoride content.”
“Dr Michael’s preparations do not have severe side effects, they are user-friendly, they do not have an unpleasant smell, and they do not stain the underwear and can successfully be applied in the case of outpatients as well.”

PDF: RussianTrial.pdf

The Results Of Attestation Study Of Effectiveness Dr. Michaels Psoriasis Products (undertaken during the years 2005-2008)

Conducted by Prof. MUDr. Jana Hercogová, CSc.

Summary results of tests on 203 patients. Very good results were achieved with chronic psoriasis, whereas in acute stages the good results were not often delivered.

The following specialists participated in this study:

S.No Name of Doctor / Professor Hospital/Institution
1 Head Physician MUDr. Štěpánka Čapková Faculty Hospital Motol
2 MUDr. Michaela Havlíčková       Faculty Hospital Královské Vinohrady
3 Prof. MUDr. Karel Pizinger     Faculty Hospital in Plzeň
4 Head Physician MUDr. Jaroslav Hoffmann Central Military Hospital in Praha
5 Doc. MUDr. Karel Ettler, CSc. Faculty Hospital in Hradec Králové
6 Head Physician MUDr. Hana Duchková, DrSc Dermatology Sanatorium in Ústí nad Labem
7 Head Physician MUDr. Hana Bučková, Ph.D. Faculty Hospital in Brno
8 Head Physician MUDr. Hana Zelenková, Ph.D DOST – Svidník, Slovensko  (Slovakia)
9 Prof. MUDr. František Novotný, DrSc. Prague Dermatology Center
10 Prof. MUDr. Jana Hercogová, CSc. Faculty Hospital Bulovka

* Prof. Novotný was monitoring patients during the years 2005–2008. The results from other dermatology workplaces come from tests conducted during the year 2008.

Average success ratio: 82.3%

PDF: the-results-of-attestation-study-of-effectiveness-2005-2008.pdf