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Completed

NCT Number: NCT01209949

Assessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris

The purpose of this study is to assess subjects' experiences using Adapalene BPO gel to treat mild to moderate acne vulgaris using efficacy measurements, quality of life instruments, and video diaries.

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Key information

Conditions

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

Age range

16 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Thomas J. Stephens and Associates

Carrollton, Texas, 75006, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female subjects, aged 16 to 25 years inclusive;
  • Subjects with mild or moderate facial acne (Investigator's Global Assessment (IGA) = 2 or 3;
  • A minimum of 10 inflammatory lesions (papules and pustules) on the face (excluding the nose);
  • Subjects who agree to be photographed at each visit;
  • Subjects who agree to be video recorded by study designated staff members. They should be able to clearly and comfortably communicate their responses to questions and express their thoughts related to their disease and treatment throughout the study

Exclusion criteria

  • Subjects with nodules, cysts, acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.) or severe acne requiring systemic treatment;
  • Subjects with a wash-out period for topical acne treatment on the face less than 30 days
  • Subjects with a wash-out period for systemic acne treatment less than 30 days with the exception of isotretinoin which requires a washout of 4 months;
  • Subjects who are currently being treated with antibiotics;
  • Subjects who foresee intensive ultraviolet (UV) exposure during the study (mountain sports, UV radiation, sunbathing, tanning beds, etc.);
  • Subjects who refuse photographic and videography procedures and/or refuse to sign a full release for their use in promotional materials

Treatment and study plan

Adapalene 0.1% and Benzoyl Peroxide 2.5% gel

Drug

Apply adapalene BPO gel once daily in the evening for 12 weeks

Other names: Epiduo® Gel

Primary outcomes

  1. Number of Participants Who Were a Success (Subject's Global Assessment of 'Clear' or 'Almost Clear') at Week 12

    Time frame: 12 weeks

    Number of participants who were a Success (Subject's Global Assessment of 'Clear or 'Almost Clear') at week 12. Subject's Global Assessment is measured on a scale (Clear, Almost Clear, Mild, Moderate, Severe, Very Severe) with Clear being best and Very Severe being worst.

Secondary outcomes

  1. Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12.

    Time frame: Week 12

    Mean percent change from baseline in lesions counts (inflammatory, non-inflammatory, and total) at week 12.

  2. Number of Participants With Tolerability Assessments Resulting in an Adverse Event

    Time frame: 12 weeks

    Number of participants with tolerability assessments resulting in an adverse event. Tolerability assessments include erythema (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Scaling (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Dryness (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Stinging/Burning (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with a score of None being best and a score of Severe being worst.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 27, 2010
Registry last updated
Aug 1, 2022

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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