Determination of antipsoriatic efficacy of topical formulations in a psoriasis plaque test - Psoriasis plaque test

• Conditions: male or female subjects with chronic plaque type psoriasis

• Registration Number: EUCTR2006-001186-42-DE
• Lead Sponsor: Astion Danmark A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-24
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

All of the following criteria have to be met for inclusion of a subject in the study:
• men and women aged 18 years or older;
• subjects with psoriasis vulgaris in a chronic stable phase and stable plaques with an area sufficient for five treatment fields;
• the physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study;
• sexually active females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen: systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide, intrauterine device (IUD), condom with intravaginal spermicide;
•written informed consent obtained.

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

Subjects are to be excluded from the study when one or more of the following conditions are met:
• subjects who require systemically acting medications for the treatment of psoriasis which might counter or influence the study objectives, e.g. corticosteroids, cytostatics;
• local treatment with antipsoriatics (except for salicylic acid in vaseline) in the 4 weeks preceding and during the study (corticosteroids 8 weeks);
• systemic treatment with antipsoriatics in the three months preceding and during the study;
• treatment with systemic or locally acting medications which might counter or influence the study aim (e.g. glucocorticosteroids, MAO inhibitors, anti-epileptic drugs, anti-psychotic drugs) or medications which are known to provoke or aggravate psoriasis, e.g. b-blocker, antimalarial drugs within two weeks before the beginning of the study and during the study;
• known allergic reactions to the active ingredients or other components of the study preparations or comparators;
• evidence of drug abuse;
• pregnancy or nursing;
• UV-therapy within four weeks before beginning and during the study;
• symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study;
• participation in another clinical trial involving pharmaceutical products in the four weeks preceding and during the study;
• in the opinion of the investigator or physician performing the initial examination the subject should not participate in the study, e. g. due to probable noncompliance or inability to understand the study and give adequately informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The purpose of this study is the assessment of the antipsoriatic efficacy of the study preparations in subjects with stable psoriatic plaques. Intraindividual comparison will be made with the active ingredient-free vehicle, two commercial references and a negative control.<br>The psoriatic infiltrate will be measured by sonography and clinical skin condition will be evaluated by scoring. In addition photodocumentation will be performed.<br>;Secondary Objective: ;Primary end point(s): Primary efficacy variables for statistical evaluation are the infiltrate thickness differences to baseline calculated for the three measurement points following the baseline visit, separately.