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

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

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Adapalene-BPO Gel

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 22470-220
    • Instituto de Dermatologia e Estética do Brasil Ltda.
  • Sao Paulo, Brazil, 02404-020
    • Instituto de Assistência Médica ao Servidor Público Estadual
  • Bahia
    • Salvador, Bahia, Brazil, 40110-160
      • Serviço de Dermatologia do Ambulatório Magalhães Neto do Complexo HUPES - Universidade Federal da Bahia
  • Goias
    • Goiania, Goias, Brazil, 74125-010
      • Instituo da Pele
  • Paraná
    • Curitiba, Paraná, Brazil, 80060-900
      • Hospital de Clinicas - Universidade Federal do Parana
  • Sao Paulo
    • Campinas, Sao Paulo, Brazil, 13020-100
      • KOLderma Instituto de Pesquisa Clínica Ltda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 35 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Adapalene-BPO Gel	Drug: Adapalene-BPO Gel; Apply 1 gram of the investigational drug every night on whole face.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy evaluation	Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 12.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary efficacy evaluation	Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 1.	Week 1
Secondary efficacy evaluation	Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 2.	Week 2
Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 2. Secondary efficacy evaluation	Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 4.	Week 4
Secondary efficacy evaluation	Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 8.	Week 8
Secondary efficacy evaluation	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.	Week 12
Safety evaluation	Local tolerability scores - Erythema, Scaling, Dryness, Stinging/Burning at each study visit.	Week 1
Safety evaluation	Local tolerability scores - Erythema, Scaling, Dryness, Stinging/Burning at each study visit.	Week 2
Safety evaluation	Local tolerability scores - Erythema, Scaling, Dryness, Stinging/Burning at each study visit.	Week 4
Safety evaluation	Local tolerability scores - Erythema, Scaling, Dryness, Stinging/Burning at each study visit.	week 8
Safety evaluation	Local tolerability scores - Erythema, Scaling, Dryness, Stinging/Burning at each study visit.	Week 12

Collaborators and Investigators

• Sponsor: Galderma Brasil Ltda.
• Investigators: Study Director: Alessandra T Nogueira, MD, Galderma Brasil Ltda.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (ACTUAL): March 1, 2011
• Study Completion (ACTUAL): April 1, 2011

Study Registration Dates

• First Submitted: June 22, 2010
• First Submitted That Met QC Criteria: June 22, 2010
• First Posted (ESTIMATE): June 23, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): March 12, 2012
• Last Update Submitted That Met QC Criteria: March 9, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Acne Vulgaris; Adapalene; Benzoyl Peroxide
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents; Adapalene
• Other Study ID Numbers: BR.10.001