Trial Outcomes & Findings for A Five Day Clinical Study to Examine the Effects of a Benzoyl Peroxide Treatment on Facial Acne Lesions (NCT NCT02052752)
NCT ID: NCT02052752
Last Updated: 2015-05-18
Results Overview
The Investigator assessed and score each target lesion's swelling (elevation), elevation scores were the actual dimensions, i.e. the value in millimeters at the lesion's highest points. Percent change in height of all three target lesions were calculated and averaged for each participant. The average lesion height at baseline was calculated for each participant. An analysis of covariance (ANCOVA) was performed with average percentage change in target lesion height as the response variable, treatment group (3% BPO or vehicle) as a main effect, and average baseline target lesion height as a covariate. A greater reduction in the percentage change in height of the target lesions indicated a better outcome measure
COMPLETED
PHASE4
90 participants
Baseline to Day 4
2015-05-18
Participant Flow
Participants were recruited at a clinical site in USA
A total of 90 participants were randomized across the three treatment groups.
Participant milestones
| Measure |
Test Product
Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
|
Vehicle Gel
The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
|
Positive Control
A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Five Day Clinical Study to Examine the Effects of a Benzoyl Peroxide Treatment on Facial Acne Lesions
Baseline characteristics by cohort
| Measure |
Test Product
n=30 Participants
Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
|
Vehicle Gel
n=30 Participants
The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
|
Positive Control
n=30 Participants
A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
22.1 Years
STANDARD_DEVIATION 9.90 • n=5 Participants
|
20.3 Years
STANDARD_DEVIATION 7.47 • n=7 Participants
|
17.8 Years
STANDARD_DEVIATION 6.22 • n=5 Participants
|
20.1 Years
STANDARD_DEVIATION 8.11 • n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
60.0 • n=5 Participants
|
17 Participants
56.7 • n=7 Participants
|
12 Participants
40.0 • n=5 Participants
|
47 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
40.0 • n=5 Participants
|
13 Participants
43.3 • n=7 Participants
|
18 Participants
60.0 • n=5 Participants
|
43 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 4Population: The analysis population consists of the intent-to-treat (ITT) population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.
The Investigator assessed and score each target lesion's swelling (elevation), elevation scores were the actual dimensions, i.e. the value in millimeters at the lesion's highest points. Percent change in height of all three target lesions were calculated and averaged for each participant. The average lesion height at baseline was calculated for each participant. An analysis of covariance (ANCOVA) was performed with average percentage change in target lesion height as the response variable, treatment group (3% BPO or vehicle) as a main effect, and average baseline target lesion height as a covariate. A greater reduction in the percentage change in height of the target lesions indicated a better outcome measure
Outcome measures
| Measure |
Test Product
n=30 Participants
Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
|
Vehicle Gel
n=30 Participants
The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
|
Positive Control
n=30 Participants
A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
|
|---|---|---|---|
|
To Assess the Percentage Change in Acne Lesion Swelling (Height) of the Target Lesion for 3% Benzoyl Peroxide (BPO) Gel Test Product Relative to the Vehicle Gel After 4 Once-daily Applications.
|
-57.42 Percentage change
Standard Error 6.229
|
-47.89 Percentage change
Standard Error 6.237
|
-53.07 Percentage change
Standard Error 6.233
|
SECONDARY outcome
Timeframe: Baseline to 2 hours, 4 hours, Day 1, Day 2 and Day 4Population: The analysis population consists of the ITT population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.
The Investigator assessed and score each target lesion's swelling (elevation), elevation scores were the actual dimensions, i.e. the value in millimeters at the lesion's highest points. Percent change in height of all three target lesions were calculated and averaged for each participant. The average lesion height at baseline was calculated for each participant
Outcome measures
| Measure |
Test Product
n=30 Participants
Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
|
Vehicle Gel
n=30 Participants
The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
|
Positive Control
n=30 Participants
A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
|
|---|---|---|---|
|
To Assess the Percentage Change in Acne Lesion Swelling (Height) for the 3% Benzoyl Peroxide Gel Test Product and Positive Control Relative to the Vehicle Gel.
From baseline to hour 2
|
-3.24 Percentage change
Standard Deviation 8.726
|
-4.65 Percentage change
Standard Deviation 10.558
|
-4.57 Percentage change
Standard Deviation 10.754
|
|
To Assess the Percentage Change in Acne Lesion Swelling (Height) for the 3% Benzoyl Peroxide Gel Test Product and Positive Control Relative to the Vehicle Gel.
From baseline to day 1
|
-21.42 Percentage change
Standard Deviation 25.578
|
-22.07 Percentage change
Standard Deviation 19.688
|
-20.22 Percentage change
Standard Deviation 25.711
|
|
To Assess the Percentage Change in Acne Lesion Swelling (Height) for the 3% Benzoyl Peroxide Gel Test Product and Positive Control Relative to the Vehicle Gel.
From baseline to day 2
|
-40.30 Percentage change
Standard Deviation 34.011
|
-37.03 Percentage change
Standard Deviation 28.968
|
-42.94 Percentage change
Standard Deviation 31.121
|
|
To Assess the Percentage Change in Acne Lesion Swelling (Height) for the 3% Benzoyl Peroxide Gel Test Product and Positive Control Relative to the Vehicle Gel.
From baseline to day 4
|
-57.22 Percentage change
Standard Deviation 36.372
|
-48.60 Percentage change
Standard Deviation 34.585
|
-52.57 Percentage change
Standard Deviation 33.580
|
|
To Assess the Percentage Change in Acne Lesion Swelling (Height) for the 3% Benzoyl Peroxide Gel Test Product and Positive Control Relative to the Vehicle Gel.
From baseline to hour 4
|
-6.02 Percentage change
Standard Deviation 9.172
|
-7.01 Percentage change
Standard Deviation 11.525
|
-5.94 Percentage change
Standard Deviation 11.774
|
SECONDARY outcome
Timeframe: Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4Population: The analysis population consists of the ITT population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.
The investigator assessed the erythema of the target lesion according to the following scale and tabulated the responses: 0=none, 1=minimal, 2=mild, 3=-moderate, 4=severe.
Outcome measures
| Measure |
Test Product
n=30 Participants
Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
|
Vehicle Gel
n=30 Participants
The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
|
Positive Control
n=30 Participants
A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
|
|---|---|---|---|
|
To Assess the Change in Acne Lesion Redness (Erythema) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel.
Change from baseline to hour 2
|
-0.04 Units on a scale
Standard Deviation 0.190
|
-0.02 Units on a scale
Standard Deviation 0.122
|
-0.03 Units on a scale
Standard Deviation 0.221
|
|
To Assess the Change in Acne Lesion Redness (Erythema) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel.
Change from baseline to hour 4
|
-0.12 Units on a scale
Standard Deviation 0.283
|
-0.06 Units on a scale
Standard Deviation 0.304
|
-0.10 Units on a scale
Standard Deviation 0.279
|
|
To Assess the Change in Acne Lesion Redness (Erythema) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel.
Change from baseline to day 1
|
-0.62 Units on a scale
Standard Deviation 0.811
|
-0.56 Units on a scale
Standard Deviation 0.639
|
-0.73 Units on a scale
Standard Deviation 0.851
|
|
To Assess the Change in Acne Lesion Redness (Erythema) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel.
Change from baseline to day 2
|
-1.26 Units on a scale
Standard Deviation 1.225
|
-1.02 Units on a scale
Standard Deviation 0.967
|
-1.36 Units on a scale
Standard Deviation 1.168
|
|
To Assess the Change in Acne Lesion Redness (Erythema) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel.
Change from baseline to day 4
|
-1.83 Units on a scale
Standard Deviation 1.228
|
-1.39 Units on a scale
Standard Deviation 1.247
|
-1.84 Units on a scale
Standard Deviation 1.303
|
SECONDARY outcome
Timeframe: Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4Population: The analysis population consists of the ITT population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.
The Investigator assessed and score each target lesion's diameter (size). Diameter scores were the actual dimensions, i.e. the value in millimeters at the lesion's widest or highest points.
Outcome measures
| Measure |
Test Product
n=30 Participants
Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
|
Vehicle Gel
n=30 Participants
The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
|
Positive Control
n=30 Participants
A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
|
|---|---|---|---|
|
To Assess the Percentage Change in Acne Lesion Diameter (Size) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel.
From baseline to hour 2
|
-0.46 Percentage change
Standard Deviation 10.920
|
-1.33 Percentage change
Standard Deviation 7.274
|
-0.33 Percentage change
Standard Deviation 7.112
|
|
To Assess the Percentage Change in Acne Lesion Diameter (Size) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel.
From baseline to hour 4
|
-0.74 Percentage change
Standard Deviation 9.397
|
-0.22 Percentage change
Standard Deviation 10.666
|
-0.63 Percentage change
Standard Deviation 9.244
|
|
To Assess the Percentage Change in Acne Lesion Diameter (Size) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel.
From baseline to day 1
|
-12.46 Percentage change
Standard Deviation 27.993
|
-12.83 Percentage change
Standard Deviation 20.836
|
-11.93 Percentage change
Standard Deviation 22.049
|
|
To Assess the Percentage Change in Acne Lesion Diameter (Size) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel.
From baseline to day 2
|
-30.98 Percentage change
Standard Deviation 38.935
|
-29.81 Percentage change
Standard Deviation 36.983
|
-37.83 Percentage change
Standard Deviation 32.315
|
|
To Assess the Percentage Change in Acne Lesion Diameter (Size) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel.
From baseline to day 4
|
-52.56 Percentage change
Standard Deviation 39.058
|
-38.78 Percentage change
Standard Deviation 44.7000
|
-44.78 Percentage change
Standard Deviation 35.933
|
SECONDARY outcome
Timeframe: Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4Population: The analysis population consists of the ITT population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.
The Skin clarity was measured using the following scale; 0 Very Clear; 1 Clear; 2 Dull; 3 Very Dull; 4 Unclear. The responses were then tabulated
Outcome measures
| Measure |
Test Product
n=30 Participants
Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
|
Vehicle Gel
n=30 Participants
The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
|
Positive Control
n=30 Participants
A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
|
|---|---|---|---|
|
To Assess the Change in Facial Skin Clarity for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel
Baseline to day 2
|
-0.8 Units on a scale
Standard Deviation 0.81
|
-0.5 Units on a scale
Standard Deviation 0.51
|
-0.7 Units on a scale
Standard Deviation 0.84
|
|
To Assess the Change in Facial Skin Clarity for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel
Baseline to day 4
|
-1.2 Units on a scale
Standard Deviation 0.90
|
-0.7 Units on a scale
Standard Deviation 0.79
|
-1.0 Units on a scale
Standard Deviation 0.98
|
|
To Assess the Change in Facial Skin Clarity for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel
Baseline to hour 2
|
0.0 Units on a scale
Standard Deviation 0.00
|
0.0 Units on a scale
Standard Deviation 0.00
|
0.0 Units on a scale
Standard Deviation 0.00
|
|
To Assess the Change in Facial Skin Clarity for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel
Baseline to hour 4
|
0.0 Units on a scale
Standard Deviation 0.00
|
0.0 Units on a scale
Standard Deviation 0.00
|
0.0 Units on a scale
Standard Deviation 0.00
|
|
To Assess the Change in Facial Skin Clarity for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel
Baseline to day 1
|
-0.2 Units on a scale
Standard Deviation 0.43
|
-0.2 Units on a scale
Standard Deviation 0.38
|
-0.3 Units on a scale
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4Population: The analysis population consists of the ITT population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.
The participants were asked to rate the overall appearance of their facial skin as; 1= Very Dissatisfied; 2= Slightly Dissatisfied; 3= Neither Satisfied nor Dissatisfied; 4= Slightly Satisfied; 5= Very Satisfied. The responses were then tabulated.
Outcome measures
| Measure |
Test Product
n=30 Participants
Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
|
Vehicle Gel
n=30 Participants
The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
|
Positive Control
n=30 Participants
A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
|
|---|---|---|---|
|
To Assess the Change in Perceptions of the Overall Appearance of Their Skin for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel
Change from baseline to hour 2
|
0.3 Units on a scale
Standard Deviation 0.84
|
0.1 Units on a scale
Standard Deviation 0.82
|
0.3 Units on a scale
Standard Deviation 0.71
|
|
To Assess the Change in Perceptions of the Overall Appearance of Their Skin for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel
Change from baseline to hour 4
|
0.4 Units on a scale
Standard Deviation 0.93
|
0.3 Units on a scale
Standard Deviation 0.99
|
0.4 Units on a scale
Standard Deviation 1.07
|
|
To Assess the Change in Perceptions of the Overall Appearance of Their Skin for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel
Change from baseline to day 1
|
0.3 Units on a scale
Standard Deviation 0.92
|
0.3 Units on a scale
Standard Deviation 1.03
|
0.4 Units on a scale
Standard Deviation 1.13
|
|
To Assess the Change in Perceptions of the Overall Appearance of Their Skin for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel
Change from baseline to day 2
|
0.5 Units on a scale
Standard Deviation 1.14
|
0.6 Units on a scale
Standard Deviation 1.03
|
0.7 Units on a scale
Standard Deviation 1.24
|
|
To Assess the Change in Perceptions of the Overall Appearance of Their Skin for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel
Change from baseline to day 4
|
0.9 Units on a scale
Standard Deviation 1.03
|
0.8 Units on a scale
Standard Deviation 1.30
|
0.8 Units on a scale
Standard Deviation 1.32
|
Adverse Events
Test Product
Vehicle Gel
Positive Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER