Study of Benzoyl Peroxide Cream for Mild to Moderate Acne Vulgaris

• ClinicalTrials.gov Identifier: NCT00558831
• Recruitment Status: Completed
• First Posted: November 15, 2007
• Results First Posted: November 22, 2010
• Last Update Posted: September 26, 2017
• Sponsor: Northwestern University
• Information provided by (Responsible Party): Amy Paller, Northwestern University

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Acne Vulgaris
• Interventions: Drug: Benzoyl Peroxide; Drug: Moisturizing Lotion
• Enrollment: 11

Participant Flow

Recruitment Details	Participants in this study were patients clinically diagnosed with acne vulgaris. Participants will be recruited from the clinic. Patients were 18 to 35 years of age with mild to moderate acne vulgaris symmetrical in appearance on both sides of the face.
Pre-assignment Details

Arm/Group Title	Subjects
Arm/Group Description	Each subject was randomized to applied benzoyl peroxide 2.5% cream formulation to one side of the face and benzoyl peroxide 2.5% cream formulation plus moisturizer to the other side of the face.
Period Title: Overall Study
Started	11
Completed	10
Not Completed	1
Reason Not Completed
Lost to Follow-up	1

Baseline Characteristics

Arm/Group Title		Subjects
Arm/Group Description		Each subject was randomized to applied benzoyl peroxide 2.5% cream formulation to one side of the face and benzoyl peroxide 2.5% cream formulation plus moisturizer to the other side of the face.
Overall Number of Baseline Participants		11
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	11 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	11 100.0%
	>=65 years	0 0.0%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	11 participants
	Female	8 72.7%
	Male	3 27.3%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	11 participants
		11

Outcome Measures

1. Primary Outcome

Title	Subject Reported Change From Baseline Scale
Description	-1=worse 0=unchanged; 1=mild improvement; 2=moderate improvement; 3=clear
Time Frame	baseline and 1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Benzoyl Peroxide 2.5% Cream	Benzoyl Peroxide 2.5% Cream Plus Moisturizing Lotion
Arm/Group Description:	[Not Specified]	[Not Specified]
Overall Number of Participants Analyzed	10	10
Measure Type: Number; Unit of Measure: Participants
-1=Worse	0	0
0=Unchanged	7	6
1=Mild Improvement	1	1
2=Moderate Improvement	1	2
3=Clear	1	1

Adverse Events

Time Frame	1 month
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Benzoyl Peroxide 2.5%		Benzoyl Peroxide 2.5% Plus Moisturizing Lotion
Arm/Group Description	[Not Specified]		[Not Specified]
All-Cause Mortality
	Benzoyl Peroxide 2.5%		Benzoyl Peroxide 2.5% Plus Moisturizing Lotion
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	Benzoyl Peroxide 2.5%		Benzoyl Peroxide 2.5% Plus Moisturizing Lotion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0.00%)		0/11 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Benzoyl Peroxide 2.5%		Benzoyl Peroxide 2.5% Plus Moisturizing Lotion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/11 (100.00%)		6/11 (54.55%)
Skin and subcutaneous tissue disorders
Dryness *	6/11 (54.55%)	10	2/11 (18.18%)	3
Burning *	4/11 (36.36%)	4	3/11 (27.27%)	3
Itching *	1/11 (9.09%)	1	1/11 (9.09%)	1
* Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT 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.

Results Point of Contact

• Name/Title: Amy Paller, MD
• Organization: Northwestern University
• Phone: 312-695-6829
• EMail: apaller@nmff.org

• Responsible Party: Amy Paller, Northwestern University
• ClinicalTrials.gov Identifier: NCT00558831
• Other Study ID Numbers: STU1884
• First Submitted: November 13, 2007
• First Posted: November 15, 2007
• Results First Submitted: October 12, 2010
• Results First Posted: November 22, 2010
• Last Update Posted: September 26, 2017