Exploratory study to assess facial tolerability after daily application of several concentrations and formulations containing CD5789 in acne subjects

Phase 1

• Conditions: Acne vulgaris; MedDRA version: 13.1Level: LLTClassification code 10000519Term: Acne vulgarisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders

• Registration Number: EUCTR2010-024214-54-BE
• Lead Sponsor: GALDERMA R&D SNC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-14
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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

Study & Design

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