Trial Outcomes & Findings for 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 (NCT NCT00837213)
NCT ID: NCT00837213
Last Updated: 2017-05-25
Results Overview
Percent change from baseline to week 16 in inflammatory acne lesions (pustules/papules)(chest and back)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
33 participants
Primary outcome timeframe
Baseline, Week 16
Results posted on
2017-05-25
Participant Flow
Recruitment period: First Subject Enrolled May 2008, Last Subject completed August 28, 2008. Types of location: Dermatology Research Center
Participant milestones
| Measure |
Benzoyl Peroxide Wash -Clindamycin Foam
Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
|
Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules
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 Study
STARTED
|
16
|
17
|
|
Overall Study
COMPLETED
|
10
|
12
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
Benzoyl Peroxide Wash -Clindamycin Foam
Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
|
Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules
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 Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
not stated
|
1
|
1
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Benzoyl Peroxide Wash -Clindamycin Foam
n=16 Participants
Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
|
Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules
n=17 Participants
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
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23.9 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
21.9 years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
22.9 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: ITT
Percent change from baseline to week 16 in inflammatory acne lesions (pustules/papules)(chest and back)
Outcome measures
| Measure |
Benzoyl Peroxide Wash -Clindamycin Foam
n=16 Participants
Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
|
Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules
n=17 Participants
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.
|
|---|---|---|
|
Percent Change in Inflammatory Acne Lesions From Baseline to Week 16
|
-52.70 Percent change
Standard Deviation 26.83
|
-48.84 Percent change
Standard Deviation 40.37
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: ITT
Percent change in Non-inflammatory acne lesions (whiteheads and blackheads)(chest and back) from baseline to week 16.
Outcome measures
| Measure |
Benzoyl Peroxide Wash -Clindamycin Foam
n=16 Participants
Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
|
Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules
n=17 Participants
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.
|
|---|---|---|
|
Percent (%) Change in Non-inflammatory Acne Lesions From Baseline to Week 16.
|
-25.27 Percent Change
Standard Deviation 45.64
|
-44.69 Percent Change
Standard Deviation 43.72
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: ITT
Percent change from baseline to week 16 in total acne lesions (inflammatory + non-inflammatory)
Outcome measures
| Measure |
Benzoyl Peroxide Wash -Clindamycin Foam
n=16 Participants
Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
|
Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules
n=17 Participants
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.
|
|---|---|---|
|
Percent Change in Total Acne Lesion Counts From Baseline to Week 16
|
-38.49 Percent Change
Standard Deviation 33.06
|
-46.11 Percent Change
Standard Deviation 39.74
|
PRIMARY outcome
Timeframe: Baseline, Weeks 4, 8,12, and 16Population: ITT
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
Outcome measures
| Measure |
Benzoyl Peroxide Wash -Clindamycin Foam
n=16 Participants
Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
|
Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules
n=17 Participants
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.
|
|---|---|---|
|
Change in Investigator Global Assessment (IGA)
Change from Baseline to Week 4
|
-0.42 Units on a scale
Standard Deviation 0.57
|
-0.61 Units on a scale
Standard Deviation 0.59
|
|
Change in Investigator Global Assessment (IGA)
Change from Baseline to Week 8
|
-0.55 Units on a scale
Standard Deviation 0.88
|
-0.85 Units on a scale
Standard Deviation 0.72
|
|
Change in Investigator Global Assessment (IGA)
Change from Baseline to Week 12
|
-1 Units on a scale
Standard Deviation 1.07
|
-1.09 Units on a scale
Standard Deviation 0.8
|
|
Change in Investigator Global Assessment (IGA)
Change from Baseline to Week 16
|
-0.9 Units on a scale
Standard Deviation 0.94
|
-1.25 Units on a scale
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: ITT
Percent change in inflammatory lesion counts (chest and back)from Baseline to Week 12
Outcome measures
| Measure |
Benzoyl Peroxide Wash -Clindamycin Foam
n=16 Participants
Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
|
Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules
n=17 Participants
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.
|
|---|---|---|
|
Percent (%) Change in Inflammatory Lesion Counts (Chest and Back) From Baseline to Week 12
|
-49.04 Percent Change
Standard Deviation 31.63
|
-45.44 Percent Change
Standard Deviation 46.09
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: ITT
Percent change in non-inflammatory lesions (chest and back) from baseline to Week 12
Outcome measures
| Measure |
Benzoyl Peroxide Wash -Clindamycin Foam
n=16 Participants
Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
|
Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules
n=17 Participants
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.
|
|---|---|---|
|
Percent Change in Non-inflammatory Lesions (Chest and Back) From Baseline to Week 12
|
-38.43 Percent change
Standard Deviation 39.75
|
-38.52 Percent change
Standard Deviation 39.03
|
SECONDARY outcome
Timeframe: Week 12Population: ITT
Percent change in total lesions (chest and back) from baseline to Week 12
Outcome measures
| Measure |
Benzoyl Peroxide Wash -Clindamycin Foam
n=16 Participants
Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
|
Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules
n=17 Participants
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.
|
|---|---|---|
|
Percent Change in Total Lesions (Chest and Back) From Baseline to Week 12
|
-44.16 Percent change
Standard Deviation 29.41
|
-41.74 Percent change
Standard Deviation 38.56
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Subjects who completed 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
Outcome measures
| Measure |
Benzoyl Peroxide Wash -Clindamycin Foam
n=10 Participants
Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
|
Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules
n=12 Participants
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.
|
|---|---|---|
|
Percentage of Particpants With IGA Score at Week 16
% Clear skin
|
0 Percent of participants
|
8.3 Percent of participants
|
|
Percentage of Particpants With IGA Score at Week 16
% Clear or Almost Clear
|
0 Percent of participants
|
8.3 Percent of participants
|
|
Percentage of Particpants With IGA Score at Week 16
% Almost Clear
|
30 Percent of participants
|
25 Percent of participants
|
|
Percentage of Particpants With IGA Score at Week 16
% Almost clear/ mild
|
10 Percent of participants
|
8.3 Percent of participants
|
|
Percentage of Particpants With IGA Score at Week 16
% Mild
|
10 Percent of participants
|
25 Percent of participants
|
|
Percentage of Particpants With IGA Score at Week 16
% Mild/ Moderate
|
20 Percent of participants
|
8.3 Percent of participants
|
|
Percentage of Particpants With IGA Score at Week 16
% Moderate
|
30 Percent of participants
|
16.7 Percent of participants
|
Adverse Events
Benzoyl Peroxide Wash -Clindamycin Foam
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Benzoyl Peroxide Wash -Clindamycin Foam
n=13 participants at risk
Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
|
Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules
n=14 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Stomach flu
|
7.7%
1/13 • Number of events 1 • 16 weeks
Subjects who had visits at the first visit (Week 4) after baseline had AEs recorded.
|
0.00%
0/14 • 16 weeks
Subjects who had visits at the first visit (Week 4) after baseline had AEs recorded.
|
|
Infections and infestations
Cough
|
7.7%
1/13 • Number of events 1 • 16 weeks
Subjects who had visits at the first visit (Week 4) after baseline had AEs recorded.
|
0.00%
0/14 • 16 weeks
Subjects who had visits at the first visit (Week 4) after baseline had AEs recorded.
|
|
Infections and infestations
Cold/ Cold symptoms
|
15.4%
2/13 • Number of events 3 • 16 weeks
Subjects who had visits at the first visit (Week 4) after baseline had AEs recorded.
|
7.1%
1/14 • Number of events 1 • 16 weeks
Subjects who had visits at the first visit (Week 4) after baseline had AEs recorded.
|
|
Nervous system disorders
Headache
|
0.00%
0/13 • 16 weeks
Subjects who had visits at the first visit (Week 4) after baseline had AEs recorded.
|
7.1%
1/14 • Number of events 1 • 16 weeks
Subjects who had visits at the first visit (Week 4) after baseline had AEs recorded.
|
|
Infections and infestations
Fever
|
0.00%
0/13 • 16 weeks
Subjects who had visits at the first visit (Week 4) after baseline had AEs recorded.
|
7.1%
1/14 • Number of events 1 • 16 weeks
Subjects who had visits at the first visit (Week 4) after baseline had AEs recorded.
|
|
Infections and infestations
Nausea/ vomiting
|
0.00%
0/13 • 16 weeks
Subjects who had visits at the first visit (Week 4) after baseline had AEs recorded.
|
7.1%
1/14 • Number of events 1 • 16 weeks
Subjects who had visits at the first visit (Week 4) after baseline had AEs recorded.
|
|
Ear and labyrinth disorders
Dizziness
|
0.00%
0/13 • 16 weeks
Subjects who had visits at the first visit (Week 4) after baseline had AEs recorded.
|
7.1%
1/14 • Number of events 1 • 16 weeks
Subjects who had visits at the first visit (Week 4) after baseline had AEs recorded.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60