Clinical trial NCT01149330: Evaluation of Efficacy and Safety of Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris
Official title: Evaluation of Efficacy and Safety of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Keywords: Adapalene
Benzoyl Peroxide
Acne Vulgaris
Lead sponsor: Galderma Brasil Ltda.
Sponsor class: INDUSTRY
First posted: 2010-06-23
Enrollment: 75
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Efficacy evaluation
timeFrame: Week 12
Secondary outcomes:
measure: Secondary efficacy evaluation
timeFrame: Week 1
measure: Secondary efficacy evaluation
timeFrame: Week 2
measure: Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 2. Secondary efficacy evaluation
timeFrame: Week 4
measure: Secondary efficacy evaluation
timeFrame: Week 8
measure: Secondary efficacy evaluation
timeFrame: Week 12
measure: Safety evaluation
timeFrame: Week 1
measure: Safety evaluation
timeFrame: Week 2
measure: Safety evaluation
timeFrame: Week 4
measure: Safety evaluation
timeFrame: week 8
measure: Safety evaluation
timeFrame: Week 12
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Serviço de Dermatologia do Ambulatório Magalhães Neto do Complexo HUPES - Universidade Federal da Bahia
state: Bahia
city: Goiania
country: Brazil
facility: Instituo da Pele
state: Goias
city: Curitiba
country: Brazil
facility: Hospital De Clínicas - Universidade Federal do Paraná
state: Paraná
city: Campinas
country: Brazil
facility: KOLderma Instituto de Pesquisa Clínica Ltda
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto de Dermatologia e Estética do Brasil Ltda.
city: Sao Paulo
country: Brazil
facility: Instituto de Assistência Médica ao Servidor Público Estadual
Study officials:
affiliation: Galderma Brasil Ltda.
name: Alessandra T Nogueira, MD
role: STUDY_DIRECTOR
References: