Doppelblinde, randomisierte, kontrollierte, klinisch-experimentelle Studie der Phase II zum Nachweis der Wirksamkeit mittels Vasokonstriktionstest von Polcortolon® N Spray gegenüber Volonimat® Salbe N und zum Nachweis der Hautverträglichkeit im Patch-Test des Vehikels von Polcortolon® N SprayDouble blind, randomized, controlled, clinical-experimental trial (phase 2) to evaluate the efficacy of Polcortolon® N Spray compared to Volominat® Salbe N (ointment) using the vasoconstriction assay and to evaluate skin tolerability of Polcortolon® N Spray and its vehicle using patch test assay - POVO-2009
- Conditions
- healthy volunteers.
- Registration Number
- EUCTR2009-015642-35-DE
- Lead Sponsor
- medphano Arzneimittel GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Signed and understood consent of the volunteers,
Signed data protection agreement
men or women(1:1), between18 - 65 years
generally healthy volunteers with healthy skin.
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
History of medikation or drug abuse,
severe disease,
skin disease in the test area,
topical treatment in the testarea,
systemic medikation with influence onto the skin,
last participation in a clinical trial in the last six months,
parallel participation in another clinical trial,
lack of understanding or lack of ability to consent,
lack of signed consent or data protection agreement,
known allergy against Triamcinolonacetonid, clobetaol-17-propionat, Sodium dodecylsulfate or other components of the spray or the ointments,
pregnancy,
reaction on vaccination,
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1. Test for equality between the spray (Polcortolon N Spray) and the ointment (Volonimat Salbe N) using the vasoconstiction test assay.<br>2. Classification of the corticosteroide in a strength class.;Secondary Objective: Skin tolerability using patch test assay.;Primary end point(s): Equaly testing of Polcortolon N Spray and Volominal Salbe N.<br>Safety of the base of Polycortolon N Spray
- Secondary Outcome Measures
Name Time Method