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OpenTrials
Completed

NCT Number: NCT00837213

Comparative Efficacy and Safety of Benzoyl Peroxide Used in Combination With Clindamycin vs. Benzoyl Peroxide Used in Combination With Clindamycin and Doxycycline in the Treatment of Moderate Acne

To compare the efficacy and safety of Benzoyl peroxide used in combination with clindamycin vs. Benzoyl peroxide used in combination with clindamycin and doxycycline in the treatment of moderate acne

Completed

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Key information

Conditions

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

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Center for Dermatology, Cosmetic and Laser Surgery, Fremont, California, United States

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About this study

To compare the efficacy and safety of Benzoyl peroxide used in combination with clindamycin vs. Benzoyl peroxide used in combination with clindamycin and doxycycline once daily in the treatment of moderate acne

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female subjects with acne vulgaris . Able to understand the requirements of the study and sign informed consent/HIPAA authorization forms.

Exclusion criteria

  • Known hypersensitivity to any of the components of the study drugs or used of prohibited medications or any medical condition that contraindicate the subject's participation in the clinical study

Treatment and study plan

Benzoyl peroxide with clindamycin

Drug

Benzoyl peroxide wash - Clindamycin foam

Other names: Acne

Benzoyl peroxide with clindamycin and doxycycline

Drug

Benzoyl peroxide wash - Clindamycin foam - Doxycycline capsules

Other names: Acne

Primary outcomes

  1. Percent Change in Inflammatory Acne Lesions From Baseline to Week 16

    Time frame: Baseline, Week 16

    Percent change from baseline to week 16 in inflammatory acne lesions (pustules/papules)(chest and back)

  2. Percent (%) Change in Non-inflammatory Acne Lesions From Baseline to Week 16.

    Time frame: Baseline, Week 16

    Percent change in Non-inflammatory acne lesions (whiteheads and blackheads)(chest and back) from baseline to week 16.

  3. Percent Change in Total Acne Lesion Counts From Baseline to Week 16

    Time frame: Baseline, Week 16

    Percent change from baseline to week 16 in total acne lesions (inflammatory + non-inflammatory)

  4. Change in Investigator Global Assessment (IGA)

    Time frame: Baseline, Weeks 4, 8,12, and 16

    Change in Investigator Global Assessment (IGA) Average values chest and back.

    IGA scale:

    0 - Clear

    0.5 - Clear/almost clear

    • Almost Clear

    1.5- Almost Clear/Mild

    • Mild

    2.5- Mild/Moderate

    • Moderate

    3.5- Moderate/Severe

Secondary outcomes

  1. Percent (%) Change in Inflammatory Lesion Counts (Chest and Back) From Baseline to Week 12

    Time frame: Baseline, Week 12

    Percent change in inflammatory lesion counts (chest and back)from Baseline to Week 12

  2. Percent Change in Non-inflammatory Lesions (Chest and Back) From Baseline to Week 12

    Time frame: Baseline, Week 12

    Percent change in non-inflammatory lesions (chest and back) from baseline to Week 12

  3. Percent Change in Total Lesions (Chest and Back) From Baseline to Week 12

    Time frame: Week 12

    Percent change in total lesions (chest and back) from baseline to Week 12

  4. Percentage of Particpants With IGA Score at Week 16

    Time frame: Baseline, Week 16

    Investigator Global Assessment (IGA) at Week 16 based on the Investigator Global Assessment

    IGA:

    0 - Clear

    0.5 - Clear/almost clear

    • Almost Clear

    1.5- Almost Clear/Mild

    • Mild

    2.5- Mild/Moderate

    • Moderate

    3.5- Moderate/Severe

Sponsors and collaborators

Lead sponsor

Stiefel, a GSK Company

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 5, 2009
Registry last updated
May 25, 2017

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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