Mild to Moderate Plaque Psoriasis MedDRA version: 9.1 Level: LLT Classification code 10037153 Term: Psoriasis
Conditions
Interventions
Product Name: Valrubicin cream 1 %
Pharmaceutical Form: Cream
INN or Proposed INN: VALRUBICIN
CAS Number: 56124620
Concentration unit: % percent
Concentration type: equal
Concentration number: 1-
Phar
Sponsors
Valderm ApS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to investigate the efficacy (ability of the test product to reduce a psoriatic plaque) of valrubicin cream 0.01 %, 0.1 % and 1 %. Primary Objective: Clinical examination: verum better than placebo at study day 13 ;Primary end point(s): Analysis of superiority of test products to placebo with respect to clinical examination at day 13.;Secondary Objective: a) Clinical examination at study day 5 after application of valrubicin cream in three different concentrations in comparison to the placebo b) Clinical examination at study days 5 and 13 after application of valrubicin cream in three different concentrations in comparison to the reference product Daivonex® c) Clinical examination at study days 5 and 13 after application of valrubicin cream in three different concentrations in comparison to the reference product Betnesol®-V d) Relative changes (given in %) from baseline ultrasound measurements: verum in three different concentrations in comparison to placebo and the two reference products e) Global tolerability of the test products at the last study day f) Safety parameters will be documented and analyzed | — |
Countries
Germany
Outcome results
None listed