EUCTR2016-002860-15-CZActive, not recruitingPhase 1
A Multi-Center, Randomized, Double-Blind, Parallel-Group Vehicle Controlled Study To Compare The Efficacy And Safety Of CD5789 50µg/g Cream Versus Vehicle Cream In Subjects With Acne Vulgaris - Double-Blind Efficacy and Safety of CD5789 50µg/g Cream versus Vehicle cream in acne vulgaris
Galderma R&D SNC0 sites1,208 target enrollmentStarted: May 11, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 1,208
Study 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, 9 years of age and older), at the Screening visit. For Russia: Male or female, 9-17 years of age OR 18 years and older, at the
- •Screening visit
- •- The Subject has a facial acne severity grade of 3 (moderate) on the Investigator Global Assessment (IGA) scale at Screening and Baseline.
- •- The subject has a minimum of 20 inflammatory lesions and 25 noninflammatory lesions on the face at Screening and Baseline.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1200
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 622
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
Exclusion Criteria
- •- The subject has severe forms of acne (e.g., acne conglobata, acne fulminans) or secondary acne form (e.g.,chloracne, drug-induced acne, etc.).
- •- The subject has more than 1 nodule on the face at Screening and Baseline.
- •- The subject has more than 1 nodule on the trunk at Screening and Baseline.
Investigators
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