evaluation of efficacy and safety of adapalene 0.1%/benzoyl peroxide 2.5% gel in the treatment of acne vulgaris

Conditions: Acne Vulgaris

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.


Eligibility 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.

Keywords: adapalene benzoyl peroxide acne vulgaris