A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO DEMONSTRATE THE EFFICACY AND SAFETY OF ADAPALENE/BENZOYL PEROXIDE TOPICAL GEL COMPARED WITH ADAPALENE TOPICAL GEL, 0.1%; BENZOYL PEROXIDE TOPICAL GEL, 2.5% AND TOPICAL GEL VEHICLE IN SUBJECTS WITH ACNE VULGARIS

• Conditions: Acne Vulgaris Treatment; MedDRA version: 8.1Level: LLTClassification code 10000519Term: Acne vulgaris

• Registration Number: EUCTR2006-004215-21-DE
• Lead Sponsor: Galderma Research & Development Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-31
• Last Update Posted: 6 May 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1656

Inclusion Criteria

1. Male and female subjects 12 years of age or older.

2. A clinical diagnosis of acne vulgaris with facial involvement.

3. A minimum of 20 but not more than 50 Inflammatory lesions (papules and pustules) on the face (excluding the nose) and not more than one acne nodule.

4. A minimum of 30 but not more than 100 Noninflammatory lesions (open comedones and closed comedones) on the face (excluding the nose).

5. A score of 3 (Moderate) on the Investigator’s Global Assessment Scale.

6. Females of childbearing potential (including pre-menstrual subjects) with a negative urine pregnancy test (UPT) or females of non-childbearing potential, defined as post menopausal (absence of menstrual bleeding for 1 year prior to enrollment), hysterectomy or bilateral oophorectomy.

6a Females of childbearing potential who agree to use an approved method of birth control for the duration of the study. Approved contraception methods include:
• Bilateral tubal ligation, IUD, double barrier methods such as condom and spermicidal or diaphragm and spermicidal or strict abstinence.
• Oral, transdermal or transmucosal, injectable or implant contraceptives which require a stable dose for at least 6 months.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. More than one acne nodule.

2. Any acne cyst.

3. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment.

Study & Design

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