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Trial record 52 of 143 for:    acne AND erythema

A Five Day Clinical Study to Examine the Effects of a Benzoyl Peroxide Treatment on Facial Acne Lesions

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ClinicalTrials.gov Identifier: NCT02052752
Recruitment Status : Completed
First Posted : February 3, 2014
Results First Posted : May 18, 2015
Last Update Posted : May 18, 2015
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Skin Diseases
Interventions Drug: 3% Benzoyl Peroxide
Drug: 3% Benzoyl Peroxide Placebo
Drug: Neutrogena Rapid Clear®
Enrollment 90
Recruitment Details Participants were recruited at a clinical site in USA
Pre-assignment Details A total of 90 participants were randomized across the three treatment groups.
Arm/Group Title Test Product Vehicle Gel Positive Control
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
Started 30 30 30
Completed 30 30 30
Not Completed 0 0 0
Arm/Group Title Test Product Vehicle Gel Positive Control Total
Hide Arm/Group Description 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 30 30 30 90
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 30 participants 90 participants
22.1  (9.90) 20.3  (7.47) 17.8  (6.22) 20.1  (8.11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 30 participants 90 participants
Female
18
  60.0%
17
  56.7%
12
  40.0%
47
  52.2%
Male
12
  40.0%
13
  43.3%
18
  60.0%
43
  47.8%
1.Primary Outcome
Title 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.
Hide Description 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
Time Frame Baseline to Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Test Product Vehicle Gel Positive Control
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 30 30 30
Mean (Standard Error)
Unit of Measure: Percentage change
-57.42  (6.229) -47.89  (6.237) -53.07  (6.233)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Product, Vehicle Gel
Comments The ANCOVA results for the primary endpoint with treatment group as a main effect and average baseline value as a covariate showed no statistically significant differences in the percentage change from baseline in swelling of the target lesions between the 3% BPO group and the vehicle control group at Day 4 for the ITT population
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.283
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title 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.
Hide Description 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
Time Frame Baseline to 2 hours, 4 hours, Day 1, Day 2 and Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Test Product Vehicle Gel Positive Control
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 30 30 30
Mean (Standard Deviation)
Unit of Measure: Percentage change
From baseline to hour 2 -3.24  (8.726) -4.65  (10.558) -4.57  (10.754)
From baseline to hour 4 -6.02  (9.172) -7.01  (11.525) -5.94  (11.774)
From baseline to day 1 -21.42  (25.578) -22.07  (19.688) -20.22  (25.711)
From baseline to day 2 -40.30  (34.011) -37.03  (28.968) -42.94  (31.121)
From baseline to day 4 -57.22  (36.372) -48.60  (34.585) -52.57  (33.580)
3.Secondary Outcome
Title To Assess the Change in Acne Lesion Redness (Erythema) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel.
Hide Description 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.
Time Frame Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Test Product Vehicle Gel Positive Control
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 30 30 30
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change from baseline to hour 2 -0.04  (0.190) -0.02  (0.122) -0.03  (0.221)
Change from baseline to hour 4 -0.12  (0.283) -0.06  (0.304) -0.10  (0.279)
Change from baseline to day 1 -0.62  (0.811) -0.56  (0.639) -0.73  (0.851)
Change from baseline to day 2 -1.26  (1.225) -1.02  (0.967) -1.36  (1.168)
Change from baseline to day 4 -1.83  (1.228) -1.39  (1.247) -1.84  (1.303)
4.Secondary Outcome
Title 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.
Hide Description 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.
Time Frame Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Test Product Vehicle Gel Positive Control
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 30 30 30
Mean (Standard Deviation)
Unit of Measure: Percentage change
From baseline to hour 2 -0.46  (10.920) -1.33  (7.274) -0.33  (7.112)
From baseline to hour 4 -0.74  (9.397) -0.22  (10.666) -0.63  (9.244)
From baseline to day 1 -12.46  (27.993) -12.83  (20.836) -11.93  (22.049)
From baseline to day 2 -30.98  (38.935) -29.81  (36.983) -37.83  (32.315)
From baseline to day 4 -52.56  (39.058) -38.78  (44.7000) -44.78  (35.933)
5.Secondary Outcome
Title To Assess the Change in Facial Skin Clarity for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel
Hide Description 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
Time Frame Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Test Product Vehicle Gel Positive Control
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 30 30 30
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline to hour 2 0.0  (0.00) 0.0  (0.00) 0.0  (0.00)
Baseline to hour 4 0.0  (0.00) 0.0  (0.00) 0.0  (0.00)
Baseline to day 1 -0.2  (0.43) -0.2  (0.38) -0.3  (0.48)
Baseline to day 2 -0.8  (0.81) -0.5  (0.51) -0.7  (0.84)
Baseline to day 4 -1.2  (0.90) -0.7  (0.79) -1.0  (0.98)
6.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Test Product Vehicle Gel Positive Control
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 30 30 30
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change from baseline to hour 2 0.3  (0.84) 0.1  (0.82) 0.3  (0.71)
Change from baseline to hour 4 0.4  (0.93) 0.3  (0.99) 0.4  (1.07)
Change from baseline to day 1 0.3  (0.92) 0.3  (1.03) 0.4  (1.13)
Change from baseline to day 2 0.5  (1.14) 0.6  (1.03) 0.7  (1.24)
Change from baseline to day 4 0.9  (1.03) 0.8  (1.30) 0.8  (1.32)
Time Frame 5 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Test Product Vehicle Gel Positive Control
Hide Arm/Group Description 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. 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. 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.
All-Cause Mortality
Test Product Vehicle Gel Positive Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Test Product Vehicle Gel Positive Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Test Product Vehicle Gel Positive Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%)   0/30 (0.00%) 
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.
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.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02052752     History of Changes
Other Study ID Numbers: 201244
RH02060 ( Other Identifier: GSK )
First Submitted: January 30, 2014
First Posted: February 3, 2014
Results First Submitted: January 8, 2015
Results First Posted: May 18, 2015
Last Update Posted: May 18, 2015