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Completed

NCT Number: NCT00671749

Combination Therapy With Differin® Gel 0.3% and Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris

This study is to determine the efficacy and safety of 12 week treatment with Differin® Gel 0.3% applied in the evening, in combination with Duac® (Clindamycin/Benzoyl Peroxide Gel) applied in the morning, in Subjects with Acne vulgaris.

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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–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Center for Dermatology and Laser Surgery, Sacramento, California, United States

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About this study

Same as above.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with a minimum of 20 inflammatory lesions on the face;
  • Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open and closed comedones) on the face, excluding the nose;
  • Subject has a Global Severity Assessment

Exclusion criteria

  • Subjects with more than three nodulo-cystic lesions

Treatment and study plan

adapalene gel, 0.3%

Drug

Applied once daily at bedtime

Other names: Differin® Gel, 0.3%

clindamycin/benzoyl peroxide gel

Drug

Applied once daily in the morning

Other names: Duac® Gel

Primary outcomes

  1. Percent Change From Baseline in Total Lesion Counts

    Time frame: 6 and 12 weeks

Secondary outcomes

  1. Global Severity Assessment Success

    Time frame: 6 and 12 weeks

    Global Severity was assessed on a 6 point scale (Clear, Almost Clear, Mild, Moderate, Severe). The scale was dichotomized to success or failure where success = Clear or Almost Clear

  2. Global Assessment of Improvement From Baseline

    Time frame: 12 weeks

  3. Worst Post Baseline Tolerability Assessment - Erythema

    Time frame: 12 weeks

    Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.

  4. Worst Post Baseline Tolerability Assessment - Scaling

    Time frame: 12 weeks

    Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.

  5. Worst Post Baseline Tolerability Assessment - Dryness

    Time frame: 12 weeks

    Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.

  6. Worst Post Baseline Tolerability Assessment - Burning/Stinging

    Time frame: 12 weeks

    Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

A Clinical Assessment of Combination Therapy With Differin® Gel, 0.3% With Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 5, 2008
Registry last updated
Aug 23, 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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