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Completed

NCT Number: NCT01138735

Epiduo Pediatric Acne Study

The purpose of this study is to evaluate the safety and efficacy of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% administered once daily for up to 12 weeks in subjects 9 to 11 years of age with acne vulgaris.

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Key information

Conditions

Acne Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

9 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Guildford Dermatology Specialists, Surrey, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of acne vulgaris with facial involvement
  • Score of 3 (moderate) on the Investigator's Global Assessment (IGA) scale
  • A minimum of 20 but not more than 100 total lesions (Noninflammatory and/or Inflammatory) on the face (including the nose) at Baseline

Exclusion criteria

  • Acne nodule or acne cyst
  • Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment
  • Underlying diseases and/or dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments
  • Use of prohibited medications prior to the study and/or are unwilling to refrain from such use during the study

Treatment and study plan

adapalene/benzoyl peroxide

Drug

daily topical application for 12 weeks

Other names: Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5%

Topical Gel Vehicle

Drug

daily topical application for 12 weeks

Primary outcomes

  1. Success Rate

    Time frame: Baseline to Week 12 (Last Observation Carried Forward [LOCF])

    Percentage of subjects rated Clear or Almost Clear with at least 2 grades reduction from Baseline on the Investigator's Global Assessment (IGA)

  2. Change From Baseline in Total Lesion Counts

    Time frame: Baseline to Week 12 (LOCF)

Secondary outcomes

  1. Percent Change in Total Lesion Counts From Baseline

    Time frame: Baseline to Week 12 (LOCF)

  2. Change in Inflammatory Lesion Counts From Baseline

    Time frame: Baseline to Week 12 (LOCF)

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

A Multi-center, Randomized, Vehicle-controlled, Double-blind, Study to Evaluate the Safety and Efficacy of Epiduo® (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% Administered Once Daily for the Treatment of Subjects 9 to 11 Years of Age With Acne Vulgaris

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 7, 2010
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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