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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

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ClinicalTrials.gov Identifier: NCT00837213
Recruitment Status : Completed
First Posted : February 5, 2009
Results First Posted : August 31, 2010
Last Update Posted : May 25, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Acne Drug: Benzoyl peroxide with clindamycin Drug: Benzoyl peroxide with clindamycin and doxycycline Phase 4

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : August 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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

    1. Almost Clear

      1.5- Almost Clear/Mild

    2. Mild

      2.5- Mild/Moderate

    3. Moderate

    3.5- Moderate/Severe



Secondary Outcome Measures :
  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

    1. Almost Clear

      1.5- Almost Clear/Mild

    2. Mild

      2.5- Mild/Moderate

    3. Moderate

    3.5- Moderate/Severe



Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00837213


Locations
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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
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: Stiefel, a GSK Company
ClinicalTrials.gov Identifier: NCT00837213    
Other Study ID Numbers: EVF0701
First Posted: February 5, 2009    Key Record Dates
Results First Posted: August 31, 2010
Last Update Posted: May 25, 2017
Last Verified: May 2017
Keywords provided by GlaxoSmithKline ( Stiefel, a GSK Company ):
Acne
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Doxycycline
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Benzoyl Peroxide
 Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents