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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 )

February 4, 2009
February 5, 2009
April 7, 2010
August 31, 2010
May 25, 2017
August 2007
August 2008   (Final data collection date for primary outcome measure)
  • 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)
  • 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.
  • 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)
  • 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

Inflamed Lesion Counts, Non-Inflamed Lesion Counts, Nodule counts, Investigator Global Assessment, Global Severity Signs, and symptoms Skin Comfort Assessment of Compliance Photography [ Time Frame: Baseline to Week 16 ]
Complete list of historical versions of study NCT00837213 on ClinicalTrials.gov Archive Site
  • 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
  • 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
  • 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
  • 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

Not Provided
Not Provided
Not Provided
 
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
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
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
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Acne
  • Drug: Benzoyl peroxide with clindamycin
    Benzoyl peroxide wash - Clindamycin foam
    Other Name: Acne
  • Drug: Benzoyl peroxide with clindamycin and doxycycline
    Benzoyl peroxide wash - Clindamycin foam - Doxycycline capsules
    Other Name: Acne
  • Active Comparator: BPO with clindamycin foam
    Benzoyl peroxide (BPO) wash with clindamycin foam
    Intervention: Drug: Benzoyl peroxide with clindamycin
  • Active Comparator: BPO + clindamycin foam + doxycycline
    Benzoyl peroxide (BPO) wash with clindamycin foam and doxycycline capsules
    Intervention: Drug: Benzoyl peroxide with clindamycin and doxycycline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
Same as current
August 2008
August 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00837213
EVF0701
No
Not Provided
Not Provided
GlaxoSmithKline ( Stiefel, a GSK Company )
Stiefel, a GSK Company
GlaxoSmithKline
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP