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

• Sponsor: GlaxoSmithKline
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Test Product	Vehicle Gel	Positive Control	Total
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
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%

Outcome Measures

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.
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

Outcome Measure Data

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
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)

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.
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

Outcome Measure Data

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
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.
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

Outcome Measure Data

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
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.
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)

Adverse Events

Time Frame	5 days
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Test Product	Vehicle Gel	Positive Control
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	--/--	--/--	--/--
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%)
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%)

Limitations and Caveats

[Not Specified]

More Information

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