Study of Benzoyl Peroxide Cream for Mild to Moderate Acne Vulgaris

This study has been completed.

Sponsor:

Information provided by:

Northwestern University

ClinicalTrials.gov Identifier:

NCT00558831

First received: November 13, 2007

Last updated: January 12, 2011

Last verified: January 2011

History of Changes

Results First Received: October 12, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Acne Vulgaris
Interventions:	Drug: Benzoyl Peroxide Drug: Moisturizing Lotion

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 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

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Subjects	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.

Participant Flow: Overall Study

	Subjects
STARTED	11
COMPLETED	10
NOT COMPLETED	1
Lost to Follow-up	1

Baseline Characteristics

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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.
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Reporting Groups

	Description
Subjects	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.

Baseline Measures

	Subjects
Number of Participants [units: participants]	11
Age [units: participants]
<=18 years	0
Between 18 and 65 years	11
>=65 years	0
Gender [units: participants]
Female	8
Male	3
Region of Enrollment [units: participants]
United States	11

Outcome Measures

1. Primary:

Subject Reported Change From Baseline Scale [ Time Frame: baseline and 1 month ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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
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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.

Results Point of Contact:

Name/Title: Amy Paller, MD
Organization: Northwestern University
phone: 312-695-6829
e-mail: apaller@nmff.org

Responsible Party:	Amy Paller, MD, Northwestern University
ClinicalTrials.gov Identifier:	NCT00558831 History of Changes
Other Study ID Numbers:	STU1884
Study First Received:	November 13, 2007
Results First Received:	October 12, 2010
Last Updated:	January 12, 2011
Health Authority:	United States: Institutional Review Board

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