A 13 day placebo- and reference-controlled, double-blind, monocentric, randomized, intraindividual comparative clinical phase IIa study, investigating the efficacy and tolerability of valrubicin cream 0.01 %, 0.1 % and 1 % in a panel of 24 patients with Psoriasis in a Psoriasis plaque test

Valderm ApS0 个研究点开始时间: 2007年9月24日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1. Plaque Psoriasis as determined by patient history and typical lesions
•2. Caucasian men and women (skin type I to IV, Fitzpatrick 1974)
•3. At least 18 years of age
•4. At least one stable psoriatic plaque (stable plaque = plaque with no major changes in the size and no new plaque formation within the last two weeks prior screening. Changes in scaling and minor changes in erythema are allowed) of approx. 10 x 10 cm (or two or three plaques with equivalent areas) in an area sufficient for product application
•5. Willingness to discontinue the use of own treatment and cosmetic products (e.g. soaps, creams, moisturizers) in the treatment areas throughout the course of the study
•6. Willingness to actively participate in the study and to comply with the scheduled visits
•7. Signed written informed consent to participate in the study has been obtained
•8. Negative urine pregnancy test (in female patients of child bearing potential)
•9. Reliable methods of contraception which result in a low failure rate (i.e. less than 1% per year) for women of childbearing potential (implants, injectables, combined oral contraceptives, some intrauterine-devices, sexual abstinence or vasectomised partner)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Acute considerable changes in the expression of the Psoriasis within the last six weeks prior to screening
•2. Topical therapy in the test region in the last two weeks that may interfere with the aim of the test, e.g. corticosteroids, vitamin D analogue containing products
•3. Pregnancy or lactation
•4. Active skin disease in the test areas, except for plaque Psoriasis
•5. Intake of drugs interfering with the immune system: Corticosteroids, antibiotics, antihistamines, immunosuppressants, antiphlogistics
•(minor pain relief medicine like acetylsalicylic acid or acetaminophene if not more than 1000 mg per day is allowed), for all: 30 days prior start of study and during conduct of study)
•6. Known hypersensitivity against plaster or against the active ingredients or excipients of the test products
•7. Moderate or severe illness within the last two weeks before first exposure
•8. Known infectious deseases (e.g. hepatitis or AIDS)
•9. Known dysfunction of calcium metabolism
•10. Intensive UV-light exposure within two weeks before the beginning of the test as well as during the study
•11. Any history of drug addiction or alcoholism in the past 3 years
•12. Participation in a clinical trial within the last 30 days prior to the start of this study
•13. Employees of the study sites or of the Sponsor company

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