EUCTR2010-024214-54-BE
Active, not recruiting
Phase 1
Exploratory study to assess facial tolerability after daily application of several concentrations and formulations containing CD5789 in acne subjects
GALDERMA R&D SNC0 sites60 target enrollmentStarted: February 14, 2011Last updated:
DrugsZorac®
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- GALDERMA R&D SNC
- Enrollment
- 60
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
- •If female of childbearing potential,she agrees to use a highly effective double\-barrier contraception method for the duration of the study and one month after the last product application.
- •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
Exclusion Criteria
- •The subject has severe forms of acne requiring systemic treatment (acne conglobata, acne fulminans) or secondary acne form (chloracne, drug\-induced acne, etc.)
- •The subject has a known allergy or sensitivity to any of the components of the study products
Investigators
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