Evaluation of Efficacy and Safety of Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to demonstrate the efficacy of Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel in the treatment of acne vulgaris. The safety will also be evaluated.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galderma Brasil Ltda.
• Treatments: Adapalene; Benzoyl Peroxide

Criteria

Inclusion Criteria:

• Male or female Subjects, aged 12 to 35 years inclusive, with moderate to severe facial acne vulgaris (described scale score of 3 or 4),

• Subjects with a minimum of 20 and a maximum of 50 Inflammatory Lesions (papules and pustules) on the face, excluding the nose,

• 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,

• 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/systemic [injectable, patch…] contraception (must have been on a stable dose for 3 months prior to study entry), Intrauterine Device, strict abstinence, condoms, diaphragms, sponge, spermicides or partner had a vasectomy,

• 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,

• Subjects have to read and sign the approved the Informed Consent form prior to any participation in the study. Subjects under the majority must sign an assent-to-participate form to participate in the study and they must have one parent or guardian read and sign the Informed Consent form prior to any study related procedure,

• Subjects willing and capable of cooperating to the extend and degree required by the protocol.

Exclusion Criteria:

• Subjects who have participated in another investigational drug or device research study within 30 days of enrollment,

• Female Subjects who are pregnant, nursing or planning a pregnancy during the study,

• Subjects with more than 1 nodule or cyst on the face

• Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.),

• Subjects with known or suspected allergy to one of the investigational products (see package insert and/or investigator brochure),

• Subjects who have pathological conditions photosensitive porphyria, SLE, LED, solar polymorphous eruption, actinic prurigo, solar urticaria, etc.

• Subjects with a beard or other facial hair that might interfere with study assessments,

• Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc...)

• Female subjects with a history of hormonal changes.

• Subjects with skin condition or disease requiring topical or systemic therapy, which interferes with the investigational product or that may directly affect the evaluation criteria:

• Topical treatment for acne in the past two weeks.

• Anti-inflammatory topic in the last two weeks.

• Use of topical corticosteroids on the face in the last four weeks.

• Anti-inflammatory systemic (hormonal or not) in the last four weeks.

• Use of systemic corticosteroids in the last four weeks.

• Systemic antibiotics in the last four weeks (excluding penicillins).

• Systemic retinoids in the last six months.

• Other systemic anti-acne the last four weeks.

• Anticonceptional oral used exclusively for the control of acne in the past six months.

• Cosmetic procedures such as facials, peels, exfoliation, extraction of comedones, application of LED, laser or pulsed light in the last two weeks.

• Cosmetic procedures such as PDT in the last four weeks.