Status:
COMPLETED
Evaluation of Efficacy and Safety of Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris
Lead Sponsor:
Galderma Brasil Ltda.
Conditions:
Acne Vulgaris
Eligibility:
All Genders
12-35 years
Phase:
PHASE4
Brief 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
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01149330
Start Date
July 1 2010
End Date
April 1 2011
Last Update
March 12 2012
Active Locations (6)
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1
Serviço de Dermatologia do Ambulatório Magalhães Neto do Complexo HUPES - Universidade Federal da Bahia
Salvador, Estado de Bahia, Brazil, 40110-160
2
Instituo da Pele
Goiânia, Goiás, Brazil, 74125-010
3
Hospital De Clínicas - Universidade Federal do Paraná
Curitiba, Paraná, Brazil, 80060-900
4
Instituto de Dermatologia e Estética do Brasil Ltda.
Rio de Janeiro, Rio de Janeiro, Brazil, 22470-220