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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 )

Tracking Information
First Submitted Date  ICMJE February 4, 2009
First Posted Date  ICMJE February 5, 2009
Results First Submitted Date  ICMJE April 7, 2010
Results First Posted Date  ICMJE August 31, 2010
Last Update Posted Date May 25, 2017
Study Start Date  ICMJE August 2007
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2010)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: February 4, 2009)
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 ]
Change History Complete list of historical versions of study NCT00837213 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2010)
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 4, 2009)
33
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00837213
Other Study ID Numbers  ICMJE EVF0701
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline ( Stiefel, a GSK Company )
Study Sponsor  ICMJE Stiefel, a GSK Company
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date May 2017

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