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

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ClinicalTrials.gov Identifier: NCT01149330
Recruitment Status : Completed
First Posted : June 23, 2010
Last Update Posted : March 12, 2012
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Adapalene-BPO Gel Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Efficacy and Safety of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris
Study Start Date : July 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: Adapalene-BPO Gel Drug: Adapalene-BPO Gel
Apply 1 gram of the investigational drug every night on whole face.




Primary Outcome Measures :
  1. Efficacy evaluation [ Time Frame: Week 12 ]
    Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 12.


Secondary Outcome Measures :
  1. Secondary efficacy evaluation [ Time Frame: Week 1 ]
    Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 1.

  2. Secondary efficacy evaluation [ Time Frame: Week 2 ]
    Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 2.

  3. Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 2. Secondary efficacy evaluation [ Time Frame: Week 4 ]
    Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 4.

  4. Secondary efficacy evaluation [ Time Frame: Week 8 ]
    Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 8.

  5. Secondary efficacy evaluation [ Time Frame: 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.


  6. Safety evaluation [ Time Frame: Week 1 ]
    Local tolerability scores - Erythema, Scaling, Dryness, Stinging/Burning at each study visit.

  7. Safety evaluation [ Time Frame: Week 2 ]
    Local tolerability scores - Erythema, Scaling, Dryness, Stinging/Burning at each study visit.

  8. Safety evaluation [ Time Frame: Week 4 ]
    Local tolerability scores - Erythema, Scaling, Dryness, Stinging/Burning at each study visit.

  9. Safety evaluation [ Time Frame: week 8 ]
    Local tolerability scores - Erythema, Scaling, Dryness, Stinging/Burning at each study visit.

  10. Safety evaluation [ Time Frame: Week 12 ]
    Local tolerability scores - Erythema, Scaling, Dryness, Stinging/Burning at each study visit.



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Ages Eligible for Study:   12 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01149330


Locations
Brazil
Serviço de Dermatologia do Ambulatório Magalhães Neto do Complexo HUPES - Universidade Federal da Bahia
Salvador, Bahia, Brazil, 40110-160
Instituo da Pele
Goiania, Goias, Brazil, 74125-010
Hospital De Clínicas - Universidade Federal do Paraná
Curitiba, Paraná, Brazil, 80060-900
KOLderma Instituto de Pesquisa Clínica Ltda
Campinas, Sao Paulo, Brazil, 13020-100
Instituto de Dermatologia e Estética do Brasil Ltda.
Rio de Janeiro, Brazil, 22470-220
Instituto de Assistência Médica ao Servidor Público Estadual
Sao Paulo, Brazil, 02404-020
Sponsors and Collaborators
Galderma Brasil Ltda.
Investigators
Study Director: Alessandra T Nogueira, MD Galderma Brasil Ltda.

Responsible Party: Alessandra Nogueira, MD, Galderma Brasil Ltda.
ClinicalTrials.gov Identifier: NCT01149330     History of Changes
Other Study ID Numbers: BR.10.001
First Posted: June 23, 2010    Key Record Dates
Last Update Posted: March 12, 2012
Last Verified: March 2012

Keywords provided by Galderma Brasil Ltda.:
Adapalene
Benzoyl Peroxide
Acne Vulgaris

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Benzoyl Peroxide
Adapalene
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents