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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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00837213
First received: February 4, 2009
Last updated: July 12, 2011
Last verified: July 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Acne
 Drug: Benzoyl peroxide with clindamycin
Drug: Benzoyl peroxide with clindamycin and doxycycline
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Acne
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Percent Change in Inflammatory Acne Lesions From Baseline to Week 16 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    Percent change from baseline to week 16 in inflammatory acne lesions (pustules/papules)(chest and back)

  • Percent (%) Change in Non-inflammatory Acne Lesions From Baseline to Week 16. [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    Percent change in Non-inflammatory acne lesions (whiteheads and blackheads)(chest and back) from baseline to week 16.

  • Percent Change in Total Acne Lesion Counts From Baseline to Week 16 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    Percent change from baseline to week 16 in total acne lesions (inflammatory + non-inflammatory)

  • Change in Investigator Global Assessment (IGA) [ Time Frame: Baseline, Weeks 4, 8,12, and 16 ] [ Designated as safety issue: No ]

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

    IGA scale:

    0 - Clear

    0.5 - Clear/almost clear

    1. Almost Clear

      1.5- Almost Clear/Mild

    2. Mild

      2.5- Mild/Moderate

    3. Moderate

    3.5- Moderate/Severe



Secondary Outcome Measures:
  • Percent (%) Change in Inflammatory Lesion Counts (Chest and Back) From Baseline to Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Percent change in inflammatory lesion counts (chest and back)from Baseline to Week 12

  • Percent Change in Non-inflammatory Lesions (Chest and Back) From Baseline to Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Percent change in non-inflammatory lesions (chest and back) from baseline to Week 12

  • Percent Change in Total Lesions (Chest and Back) From Baseline to Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Percent change in total lesions (chest and back) from baseline to Week 12

  • Percentage of Particpants With IGA Score at Week 16 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]

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

    IGA:

    0 - Clear

    0.5 - Clear/almost clear

    1. Almost Clear

      1.5- Almost Clear/Mild

    2. Mild

      2.5- Mild/Moderate

    3. Moderate

    3.5- Moderate/Severe



Enrollment: 33
Study Start Date: August 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BPO with clindamycin foam
Benzoyl peroxide (BPO) wash with clindamycin foam
 Drug: Benzoyl peroxide with clindamycin
Benzoyl peroxide wash - Clindamycin foam
Other Name: Acne
Active Comparator: BPO + clindamycin foam + doxycycline
Benzoyl peroxide (BPO) wash with clindamycin foam and doxycycline capsules
 Drug: Benzoyl peroxide with clindamycin and doxycycline
Benzoyl peroxide wash - Clindamycin foam - Doxycycline capsules
Other Name: Acne

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00837213

Locations
United States, California
Center for Dermatology, Cosmetic and Laser Surgery
Fremont, California, United States, 94538
United States, Nevada
Las Vegas Skin & Cancer Clinic
Las Vegas, Nevada, United States, 89129
Sponsors and Collaborators
Stiefel, a GSK Company
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri A. Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00837213     History of Changes
Other Study ID Numbers: EVF0701
Study First Received: February 4, 2009
Results First Received: April 7, 2010
Last Updated: July 12, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by GlaxoSmithKline:
Acne

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Benzoyl Peroxide
Clindamycin
Clindamycin-2-phosphate
Doxycycline
Doxycycline hyclate
Dermatologic Agents
 Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 16, 2013