Study of Two Different 10.0% Benzoyl Peroxide Creams for Mild to Moderate Acne Vulgaris

This study has been completed.

Sponsor:

Information provided by:

Northwestern University

ClinicalTrials.gov Identifier:

NCT00787943

First received: November 6, 2008

Last updated: November 19, 2010

Last verified: November 2010

History of Changes

Results First Received: September 24, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Acne Vulgaris
Intervention:	Drug: topical benzoyl peroxide 10.0% cream - Formulations #1 and #2

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from the clinic, as well as advertising in the Department of Dermatology.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
All Study Participants	Apply Formula #1 to assigned side of face twice daily. Apply Formula #2 to assigned side of face twice daily.

Participant Flow: Overall Study

	All Study Participants
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
All Study Participants	Apply Formula #1 to assigned side of face twice daily. Apply Formula #2 to assigned side of face twice daily.

Baseline Measures

	All Study Participants
Number of Participants [units: participants]	10
Age [units: participants]
<=18 years	0
Between 18 and 65 years	10
>=65 years	0
Gender [units: Participants]
Female	6
Male	4
Region of Enrollment [units: participants]
United States	10

Outcome Measures

1. Primary:

Number of Inflammatory Lesions (Papules and Pustules) [ Time Frame: 4 Weeks ]

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Measure Type	Primary
Measure Title	Number of Inflammatory Lesions (Papules and Pustules)
Measure Description	Assessment will be done based on lesion counting. We will compare the lesions treated twice daily with the benzoyl peroxide 10.0% cream Formulation #1 vs. the benzoyl peroxide 10.0% cream Formulation #2.
Time Frame	4 Weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Papules and pustules were analyzed on the left and right side of the face for each of the 10 subjects. Analysis was per protocol with intention to treat.

Reporting Groups

	Description
Papules: Benzoyl Peroxide 10.0% Cream Formulation #1	Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible.
Pustules: Benzoyl Peroxide 10.0% Cream Formulation #1	Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible.
Papules: Benzoyl Peroxide 10.0% Cream Formulation #2	Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible.
Pustules: Benzoyl Peroxide 10.0% Cream Formulation #2	Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible.

Measured Values

	Papules: Benzoyl Peroxide 10.0% Cream Formulation #1	Pustules: Benzoyl Peroxide 10.0% Cream Formulation #1	Papules: Benzoyl Peroxide 10.0% Cream Formulation #2	Pustules: Benzoyl Peroxide 10.0% Cream Formulation #2
Number of Participants Analyzed [units: participants]	10	10	10	10
Number of Inflammatory Lesions (Papules and Pustules) [units: Lesions]
Subject 1 Day 0	6	3	10	0
Subject 1 Day 2	1	0	5	1
Subject 1 Day 7	1	0	1	0
Subject 1 Day 28	6	1	4	2
Subject 2 Day 0	14	2	7	0
Subject 2 Day 2	15	1	12	2
Subject 2 Day 7	7	0	4	0
Subject 2 Day 28	7	0	8	9
Subject 3 Day 0	7	0	9	6
Subject 3 Day 2	8	0	7	0
Subject 3 Day 7	5	3	11	1
Subject 3 Day 28	8	0	0	1
Subject 4 Day 0	14	4	6	1
Subject 4 Day 2	20	1	4	1
Subject 4 Day 7	21	0	7	1
Subject 4 Day 28	10	1	9	1
Subject 5 Day 0	23	1	23	2
Subject 5 Day 2	26	18	28	21
Subject 5 Day 7	31	0	31	4
Subject 5 Day 28	26	1	29	2
Subject 6 Day 0	22	2	6	3
Subject 6 Day 2	14	0	6	2
Subject 6 Day 7	10	1	10	1
Subject 6 Day 28	12	1	11	0
Subject 7 Day 0	34	6	30	5
Subject 7 Day 2	47	3	34	7
Subject 7 Day 7	46	3	53	1
Subject 7 Day 28	35	6	33	4
Subject 8 Day 0	9	1	7	1
Subject 8 Day 2	11	0	5	0
Subject 8 Day 7	10	0	3	0
Subject 8 Day 28	6	0	7	0
Subject 9 Day 0	17	1	19	1
Subject 9 Day 2	21	0	19	0
Subject 9 Day 7	22	0	14	0
Subject 9 Day 28	13	0	11	0
Subject 10 Day 0	13	2	13	4
Subject 10 Day 2	15	0	18	1
Subject 10 Day 7	13	1	7	2
Subject 10 Day 28	6	1	9	0

No statistical analysis provided for Number of Inflammatory Lesions (Papules and Pustules)

Serious Adverse Events

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Other Adverse Events

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More Information

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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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Amy Paller, MD
Organization: Northwestern University
phone: 773-327-9642
e-mail: apaller@northwestern.edu

No publications provided

Responsible Party:	Amy Paller, MD, Northwestern University Department of Dermatology
ClinicalTrials.gov Identifier:	NCT00787943 History of Changes
Other Study ID Numbers:	AP-032408
Study First Received:	November 6, 2008
Results First Received:	September 24, 2010
Last Updated:	November 19, 2010
Health Authority:	United States: Institutional Review Board

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