Studying the Effects of 50 µg/g Cream versus Vehicle on Subjects who have Acne.

Phase 1

• Conditions: Acne Vulgaris; MedDRA version: 19.1Level: LLTClassification code 10000519Term: Acne vulgarisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2015-002540-13-HU
• Lead Sponsor: Galderma R&D SNC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-30
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

1. Male or female, 9 years of age and older, at the Screening visit.
2. The Subject has a facial acne severity grade of 3 (moderate) on the Investigator Global Assessment (IGA) scale at Screening and Baseline.
3. The subject has a minimum of 20 inflammatory lesions and 25 noninflammatory lesions on the face at Screening and Baseline.
The subject has truncal acne severity grade of 3 (moderate) on the Physician Global assessment (PGA) scale at Screening and Baseline visits on trunk
(shoulders, upper back and upper anterior chest) reachable for self-application of study drug by the subject (optional criterion for subject between 9 and 11 years of age).
Are the trial subjects under 18? yes
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 478
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

1. The subject has severe forms of acne (e.g., acne conglobata, acne fulminans) or secondary acne form (e.g.,chloracne, drug-induced acne, etc.).
2. The subject has more than 1 nodule on the face at Screening and Baseline.
3. The subject has more than 1 nodule on the trunk at Screening and Baseline.
4. The subject has any acne cyst on the trunk at Screening and at Baseline.

Study & Design

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