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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Acne
Interventions Drug: Benzoyl peroxide with clindamycin
Drug: Benzoyl peroxide with clindamycin and doxycycline
Enrollment 33
Recruitment Details

Recruitment period: First Subject Enrolled May 2008, Last Subject completed August 28, 2008.

Types of location: Dermatology Research Center
Pre-assignment Details  
Arm/Group Title Benzoyl Peroxide Wash -Clindamycin Foam Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules
Hide Arm/Group Description Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
Period Title: Overall Study
Started 16 17
Completed 10 12
Not Completed 6 5
Reason Not Completed
Lost to Follow-up             3             2
Withdrawal by Subject             2             2
not stated             1             1
Arm/Group Title Benzoyl Peroxide Wash -Clindamycin Foam Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules Total
Hide Arm/Group Description Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day. Total of all reporting groups
Overall Number of Baseline Participants 16 17 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 17 participants 33 participants
23.9  (8.5) 21.9  (6.9) 22.9  (7.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 17 participants 33 participants
Female
7
  43.8%
9
  52.9%
16
  48.5%
Male
9
  56.3%
8
  47.1%
17
  51.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 16 participants 17 participants 33 participants
White 10 12 22
Asian 3 0 3
Hispanic 2 3 5
Black or African American 1 2 3
1.Primary Outcome
Title Percent Change in Inflammatory Acne Lesions From Baseline to Week 16
Hide Description Percent change from baseline to week 16 in inflammatory acne lesions (pustules/papules)(chest and back)
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Benzoyl Peroxide Wash -Clindamycin Foam Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules
Hide Arm/Group Description:
Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
Overall Number of Participants Analyzed 16 17
Mean (Standard Deviation)
Unit of Measure: Percent change
-52.70  (26.83) -48.84  (40.37)
2.Primary Outcome
Title Percent (%) Change in Non-inflammatory Acne Lesions From Baseline to Week 16.
Hide Description Percent change in Non-inflammatory acne lesions (whiteheads and blackheads)(chest and back) from baseline to week 16.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Benzoyl Peroxide Wash -Clindamycin Foam Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules
Hide Arm/Group Description:
Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
Overall Number of Participants Analyzed 16 17
Mean (Standard Deviation)
Unit of Measure: Percent Change
-25.27  (45.64) -44.69  (43.72)
3.Primary Outcome
Title Percent Change in Total Acne Lesion Counts From Baseline to Week 16
Hide Description Percent change from baseline to week 16 in total acne lesions (inflammatory + non-inflammatory)
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Benzoyl Peroxide Wash -Clindamycin Foam Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules
Hide Arm/Group Description:
Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
Overall Number of Participants Analyzed 16 17
Mean (Standard Deviation)
Unit of Measure: Percent Change
-38.49  (33.06) -46.11  (39.74)
4.Primary Outcome
Title Change in Investigator Global Assessment (IGA)
Hide Description

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
Time Frame Baseline, Weeks 4, 8,12, and 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Benzoyl Peroxide Wash -Clindamycin Foam Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules
Hide Arm/Group Description:
Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
Overall Number of Participants Analyzed 16 17
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change from Baseline to Week 4 -0.42  (0.57) -0.61  (0.59)
Change from Baseline to Week 8 -0.55  (0.88) -0.85  (0.72)
Change from Baseline to Week 12 -1  (1.07) -1.09  (0.8)
Change from Baseline to Week 16 -0.9  (0.94) -1.25  (0.97)
5.Secondary Outcome
Title Percent (%) Change in Inflammatory Lesion Counts (Chest and Back) From Baseline to Week 12
Hide Description Percent change in inflammatory lesion counts (chest and back)from Baseline to Week 12
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Benzoyl Peroxide Wash -Clindamycin Foam Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules
Hide Arm/Group Description:
Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
Overall Number of Participants Analyzed 16 17
Mean (Standard Deviation)
Unit of Measure: Percent Change
-49.04  (31.63) -45.44  (46.09)
6.Secondary Outcome
Title Percent Change in Non-inflammatory Lesions (Chest and Back) From Baseline to Week 12
Hide Description Percent change in non-inflammatory lesions (chest and back) from baseline to Week 12
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Benzoyl Peroxide Wash -Clindamycin Foam Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules
Hide Arm/Group Description:
Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
Overall Number of Participants Analyzed 16 17
Mean (Standard Deviation)
Unit of Measure: Percent change
-38.43  (39.75) -38.52  (39.03)
7.Secondary Outcome
Title Percent Change in Total Lesions (Chest and Back) From Baseline to Week 12
Hide Description Percent change in total lesions (chest and back) from baseline to Week 12
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Benzoyl Peroxide Wash -Clindamycin Foam Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules
Hide Arm/Group Description:
Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
Overall Number of Participants Analyzed 16 17
Mean (Standard Deviation)
Unit of Measure: Percent change
-44.16  (29.41) -41.74  (38.56)
8.Secondary Outcome
Title Percentage of Particpants With IGA Score at Week 16
Hide Description

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
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who completed week 16
Arm/Group Title Benzoyl Peroxide Wash -Clindamycin Foam Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules
Hide Arm/Group Description:
Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
Overall Number of Participants Analyzed 10 12
Measure Type: Number
Unit of Measure: Percent of participants
% Clear skin 0 8.3
% Clear or Almost Clear 0 8.3
% Almost Clear 30 25
% Almost clear/ mild 10 8.3
% Mild 10 25
% Mild/ Moderate 20 8.3
% Moderate 30 16.7
Time Frame 16 weeks
Adverse Event Reporting Description Subjects who had visits at the first visit (Week 4) after baseline had AEs recorded.
 
Arm/Group Title Benzoyl Peroxide Wash -Clindamycin Foam Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules
Hide Arm/Group Description Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
All-Cause Mortality
Benzoyl Peroxide Wash -Clindamycin Foam Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Benzoyl Peroxide Wash -Clindamycin Foam Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/14 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Benzoyl Peroxide Wash -Clindamycin Foam Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/13 (30.77%)      4/14 (28.57%)    
Ear and labyrinth disorders     
Dizziness * 1  0/13 (0.00%)  0 1/14 (7.14%)  1
Infections and infestations     
Stomach flu * 1  1/13 (7.69%)  1 0/14 (0.00%)  0
Cough * 1  1/13 (7.69%)  1 0/14 (0.00%)  0
Cold/ Cold symptoms * 1  2/13 (15.38%)  3 1/14 (7.14%)  1
Fever * 1  0/13 (0.00%)  0 1/14 (7.14%)  1
Nausea/ vomiting * 1  0/13 (0.00%)  0 1/14 (7.14%)  1
Nervous system disorders     
Headache * 1  0/13 (0.00%)  0 1/14 (7.14%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, not used
Small sample size did not provide adequate power. Even with the limited sample size, total lesion counts provides a more reliable view of the study data due to the greater number of lesions to work with.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT00837213    
Other Study ID Numbers: EVF0701
First Submitted: February 4, 2009
First Posted: February 5, 2009
Results First Submitted: April 7, 2010
Results First Posted: August 31, 2010
Last Update Posted: May 25, 2017