A Five Day Clinical Study to Examine the Effects of a Benzoyl Peroxide Treatment on Facial Acne Lesions
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
---|---|---|---|
![]() |
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 | |
---|---|---|---|---|---|
![]() |
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 | |
![]() |
[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
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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 |
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 |