Study of Benzoyl Peroxide Cream for Mild to Moderate Acne Vulgaris

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00558831

First Posted: November 15, 2007

Last Update Posted: September 26, 2017

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.

Information provided by (Responsible Party):

Amy Paller, Northwestern University

Results First Submitted: October 12, 2010

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

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
Overall Participants Analyzed [Units: Participants]	11

Age [Units: Participants] Count of Participants
<=18 years	0 0.0%
Between 18 and 65 years	11 100.0%
>=65 years	0 0.0%

Sex: Female, Male [Units: Participants] Count of Participants
Female	8 72.7%
Male	3 27.3%

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, Northwestern University
ClinicalTrials.gov Identifier:	NCT00558831 History of Changes
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

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