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

NCT01149330 | Completed Phase 4

• 1 other identifier: BR.10.001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 6

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.

Conditions

Acne Vulgaris

Keywords

Adapalene; Benzoyl Peroxide; Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Efficacy evaluation

  Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 12.

  Week 12

Secondary Outcomes (10)

• Secondary efficacy evaluation

  Week 1

• Secondary efficacy evaluation

  Week 2

• Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 2. Secondary efficacy evaluation

  Week 4

• Secondary efficacy evaluation

  Week 8

• Secondary efficacy evaluation

  Week 12

Study Arms (1)

Adapalene-BPO Gel

EXPERIMENTAL

Drug: Adapalene-BPO Gel

Interventions

Adapalene-BPO Gel DRUG

Apply 1 gram of the investigational drug every night on whole face.

Adapalene-BPO Gel

Eligibility Criteria

• Age: 12 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galderma Brasil Ltda.: lead

Study Sites (6)

Serviço de Dermatologia do Ambulatório Magalhães Neto do Complexo HUPES - Universidade Federal da Bahia

Salvador, Estado de Bahia, 40110-160, Brazil

Location

Instituo da Pele

Goiânia, Goiás, 74125-010, Brazil

Location

Hospital De Clínicas - Universidade Federal do Paraná

Curitiba, Paraná, 80060-900, Brazil

Location

Instituto de Dermatologia e Estética do Brasil Ltda.

Rio de Janeiro, Rio de Janeiro, 22470-220, Brazil

Location

KOLderma Instituto de Pesquisa Clínica Ltda

Campinas, São Paulo, 13020-100, Brazil

Location

Instituto de Assistência Médica ao Servidor Público Estadual

São Paulo, São Paulo, 02404-020, Brazil

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Alessandra T Nogueira, MD

  Galderma Brasil Ltda.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 22, 2010
• First Posted: June 23, 2010
• Study Start: July 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: April 1, 2011
• Last Updated: March 12, 2012

Record last verified: 2012-03

Locations

BR (6)