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

Phase 4

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Adapalene-BPO Gel

• Registration Number: NCT01149330
• Lead Sponsor: Galderma Brasil Ltda.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-22
• Study First Submitted QC: 2010-06-22
• Study First Posted: 2010-06-23
• Study Start: 2010-07
• Primary Completion: 2011-03
• Study Completion: 2011-04
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-09
• Last Update Posted: 2012-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adapalene-BPO Gel	Adapalene-BPO Gel	-

Primary Outcome Measures

Name	Time	Method
Efficacy evaluation	Week 12	Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 12.

Secondary Outcome Measures

Name	Time	Method
Secondary efficacy evaluation	Week 12	Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 12.; Assessment of the severity of facial acne. Evaluation of global improvement at study completion. Assessment of improvement and patient satisfaction.
Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 2. Secondary efficacy evaluation	Week 4	Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 4.
Safety evaluation	Week 12	Local tolerability scores - Erythema, Scaling, Dryness, Stinging/Burning at each study visit.

Trial Locations

Locations (6)

Serviço de Dermatologia do Ambulatório Magalhães Neto do Complexo HUPES - Universidade Federal da Bahia; 🇧🇷 Salvador, Bahia, Brazil

KOLderma Instituto de Pesquisa Clínica Ltda; 🇧🇷 Campinas, Sao Paulo, Brazil

Instituo da Pele; 🇧🇷 Goiania, Goias, Brazil

Hospital De Clínicas - Universidade Federal do Paraná; 🇧🇷 Curitiba, Paraná, Brazil

Instituto de Assistência Médica ao Servidor Público Estadual; 🇧🇷 Sao Paulo, Brazil

Instituto de Dermatologia e Estética do Brasil Ltda.; 🇧🇷 Rio de Janeiro, Brazil