Efficacy and Safety of a Fixed Combination Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Compared to Clindamycin 1% / Benzoyl Peroxide 5% Gel in the Treatment of Acne Vulgaris

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 280

Inclusion Criteria

1.Male or female Subjects of any race, aged 12 to 35 years inclusive, with facial acne vulgaris
2.Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face
3. Subjects with a minimum of 30 and a maximum of 100 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose,
4.Female Subjects of childbearing potential with a negative urine pregnancy test at the Baseline visit and must practice a highly effective method of contraception during the study: oral contraception (must have been on a stable dose for 3 months prior to study entry), IUD, systemic (injectable or patch) contraception, strict abstinence or partner had a vasectomy,
5.Females of non-childbearing potential, i.e., premenses, post-menopausal (absence of menstrual bleeding for 2 years), hysterectomy, bilateral tubal ligation, or bilateral ovariectomy, secondary infertility and sterility are not required to have a UPT at the beginning of the study,
6.Subjects aged 18 years (16 years in UK) or older have to read and sign the approved Informed Consent form prior to any participation in the study. Subjects under the age of 18 (16 in UK) may sign an assent form to participate in the study and they must have one parent or guardian (both parents for the German) sites read and sign the Informed Consent form prior to any study related procedure but the parent(s) or guardian is not required to attend the follow-up visits unless requested,
7.Subjects willing and capable of cooperating to the extend and degree required by the protocol.

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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Subjects with acne cystic lesions
2.Female Subjects who are pregnant, nursing or planning a pregnancy during the study
3.Subjects with a condition or who are in a situation which, in the Investigator’s opinion, may put the Subject at risk (including history of regional enteritis or ulcerative colitis or a history of antibiotic associated colitis), may confound the study results, or may interfere with the Subject’s participation in the study
4.Subjects with known allergy to one of the components of the test products (see package insert and/or investigator brochure)
5.Subjects who have participated in another investigational drug or device research study within 30 days of enrollment
6.Subjects with a specified wash-out period for topical treatment on the face (refer to study protocol for details)
7.Subjects with a specified wash-out period for systemic treatment (refer to study protocol for details)
8.Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)
9.Subjects with a beard or other facial hair that might interfere with study assessments
10.Subjects who are at risk in terms of precautions, warnings, and contra-indication (see package insert and/or investigator brochure),
11.Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc...).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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