PILOT STUDY TO EXPLORE EFFICACY AND SAFETY OF DIFFERENT DOSE REGIMENS OF CD5789 IN SUBJECTS WITH ACNE VULGARIS
- Conditions
- Acne vulgarisMedDRA version: 12.1Level: LLTClassification code 10000519Term: Acne vulgaris
- Registration Number
- EUCTR2010-022211-19-BE
- Lead Sponsor
- GALDERMA R&D
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
* Male or female subject aged from 18 to 35 years old
* The subject has medical diagnosis of moderate to severe acne vulgaris on the face
* The subject has, on the face, at least 20 inflammatory lesions and 30 non-inflammatory lesions
* The Subject has a severity grade of 3 or 4 on the Investigator’s Global Assessment (IGA) scale on either side of the face
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) no
F.1.3.1 Number of subjects for this age range
* The subject has more than 2 acne nodules/cysts on the face
* The subject has severe forms of acne (acne conglobata, acne fulminans) or secondary acne form (chloracne, drug-induced acne, etc.)
* The number of inflammatory or non inflammatory lesions on half-face is greater than twice the number on the other half-face
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the impact of different dose regimen: 5 times a week and twice a week as leave-on applications and short contact applications (5 minutes and 30 minutes), on efficacy and safety of the treatment with CD 5789 100µg/g in a gel formulation in subjects with moderate to severe acne vulgaris.;Secondary Objective: - Efficacy objectives<br>- Safety objectives;Primary end point(s): Total acne lesion count and percent reduction at end of treatment
- Secondary Outcome Measures
Name Time Method