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Completed

NCT Number: NCT00422240

Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris

This was a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations were performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a participant should remain the same during the study.

The primary objective was to demonstrate the superiority in efficacy and assess safety of adapalene/benzoyl peroxide topical gel (adapalene/benzoyl peroxide gel) versus adapalene topical gel, 0.1% (adapalene monad); benzoyl peroxide topical gel, 2.5% (benzoyl peroxide monad) and topical gel vehicle (gel vehicle) in the treatment of acne vulgaris for up to 12 weeks.

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Key information

Conditions

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

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Miller MD

San Antonio, Texas, 78229, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A clinical diagnosis of acne vulgaris with facial involvement.
  • A minimum of 20 but not more than 50 inflammatory lesions
  • A minimum of 30 but not more than 100 noninflammatory lesions
  • A score of 3 (Moderate) on the Investigator's Global Assessment Scale

Treatment and study plan

adapalene/benzoyl peroxide

Drug

Adapalene 0.1 % [weight by weight (W/W)]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks.

Adapalene Gel, 0.1%

Drug

0.1% of adapalene gel topically daily in the evening for 12 Weeks.

Benzoyl Peroxide Gel 2.5%

Drug

2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks.

Gel Vehicle

Drug

Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.

Primary outcomes

  1. Percentage of Participants Who Achieved Success Rate 0 (Clear) or 1 (Almost Clear) on the Investigator Global Assessment (IGA) Scale at Week 12 (Last Observation Carried Forward)

    Time frame: At Week 12

    Success rate was defined as percentage of participants who achieved "Clear" or "Almost Clear" score on the IGA scale. IGA scale consisted of 5 grades (0-4) among which 0 = Clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting), 1 = Almost clear (Trace, faint pink erythema with almost no induration/papulation and no oozing/crusting), 2 = Mild (Faint pink erythema with mild induration/papulation and no oozing/crusting), 3 = Moderate (Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting.), 4 = Severe (Deep/bright red erythema with severe induration/papulation with oozing/crusting). All missing values were imputed by LOCF.

  2. Change in Inflammatory Lesion Count From Baseline to Week 12

    Time frame: Baseline to Week 12

    Change in inflammatory lesion count from baseline to week 12 was reported. All missing values were imputed by LOCF.

  3. Change in Noninflammatory Lesion Count From Baseline to Week 12

    Time frame: Baseline to Week 12

    Change in noninflammatory lesion count from baseline to week 12 was reported. All missing values were imputed by LOCF.

Secondary outcomes

  1. Percent Change From Baseline in Inflammatory Lesion Counts at Week 12

    Time frame: Baseline, Week 12

    The Inflammatory Lesion Count was the sum of papules and pustules. Percent change from Baseline was calculated as the values at Week 12 minus the value at Baseline divided by Baseline value * 100. All missing values were imputed by LOCF.

  2. Percent Change From Baseline in Noninflammatory Lesion Counts at Week 12

    Time frame: Baseline, Week 12

    The Noninflammatory Lesion Count was the sum of open comedones and closed comedones. Percent change from Baseline was calculated as the values at Week 12 minus the value at Baseline divided by Baseline value * 100. All missing values were imputed by LOCF.

  3. Percent Change From Baseline in Total Lesion Counts at Week 12

    Time frame: Baseline, Week 12

    The Total Lesion Count was the sum of Inflammatory, Noninflammatory Lesion Counts, Nodules and Cysts.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

A Multi-Center, Randomized, Double-Blind, Parallel-Group Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel Compared With Adapalene Topical Gel, 0.1%; Benzoyl Peroxide Topical Gel, 2.5% and Topical Gel Vehicle in Subjects With Acne Vulgaris

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jan 15, 2007
Registry last updated
Apr 15, 2024

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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