- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00558831
Study of Benzoyl Peroxide Cream for Mild to Moderate Acne Vulgaris
August 28, 2017 updated by: Amy Paller, Northwestern University
A Split-face, Paired-comparison Pilot Study to Evaluate the Safety and Efficacy of Topical Benzoyl Peroxide 2.5% Cream Alone Versus Benzoyl Peroxide 2.5% Cream Plus Moisturizing Lotion for Mild to Moderate Acne Vulgaris
The purpose of this study is to compare the efficacy of a benzoyl peroxide 2.5% cream formulation plus a moisturizing lotion versus benzoyl peroxide 2.5% cream alone for the treatment of acne vulgaris.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to compare the safety and efficacy of a benzoyl peroxide 2.5% cream formulation plus a moisturizing lotion versus benzoyl peroxide 2.5% cream alone for mild to moderate acne vulgaris.
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University Department of Dermatology
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy male or female subjects who are 18 to 35 years of age.
- Subjects are in good health and are free of any other facial skin disorders that may interfere with acne study assessments.
- Subjects have the willingness and ability to understand and provide informed assent/consent to participate in the study and are able to communicate with the investigator. Subjects are willing and able to follow all study directions and to commit to all follow-up visits for the duration of the study. In addition, subjects must be willing to accept the restrictions of the study.
- A minimum of 2 but no more than 30 inflammatory lesions (papules and pustules), relatively symmetrical in appearance on both sides of the face and a minimum of 2 but not more than 100 non-inflammatory lesions (open comedones and closed comedones) relatively symmetrical in appearance on both sides of the face.
- Ongoing oral medications (other than those specifically for acne) are acceptable provided subjects are on a stable regimen throughout the study and provided the medications are determined likely to not interfere with study assessments.
- Subjects will not use medicated cosmetics and/or soaps (including soaps containing antibacterial agents such as benzoyl peroxide, keratolytic agents such as salicylic acid, skin fresheners/astringents or aftershave lotions) for the duration of the study.
- Subjects who agree not use any other acne treatment (including prescription and non-prescription medications) on the test site for the duration of the study.
- Subjects who agree not to change facial cosmetic products during the study.
- Subjects who agree to only use sunscreen/sunblock agents that are labeled as non-comedogenic.
Exclusion Criteria:
- Subjects or parents of subjects who are unable to understand the protocol or to give informed consent/assent.
- Subjects with mental illness.
- Subjects with no inflammatory acne.
- Subjects with any acne cysts or nodules.
- Subjects with acne conglobata, acne fulminans, secondary acne (e.g. Chloracne, drug-induced acne), or any acne requiring systemic treatment.
- Subjects with excessive facial hair that may interfere with study assessments.
- Subjects with other facial skin disorders that may interfere with study assessments.
- Subjects with a history of skin cancer or actinic keratosis.
- Subjects who have used tanning devices within one week prior to baseline study visit.
- Subjects who have applied any topical products (e.g. emollients, sunscreens) or any cosmetics to the face at least one hour prior to study assessments.
- Use of hormonal oral contraceptives for acne control or for less than 6 months prior to study baseline.
- Subjects with known allergies, a history of, or sensitive to salicylic acid, benzoyl peroxide or any of the test article components.
- Subjects using topical or systemic medication within 14 days before the study entry, which could interfere with study assessments. This includes but is not limited to the following: anti-inflammatory drugs (e.g. topical and systemic corticosteroids and systemic antihistamines), anti-acne drugs, topical and oral retinoids, topical antibacterial agents to the face, and any immunosuppressive drugs. Ongoing oral medications not expected to interfere with study assessments are allowed if the subject is on a stable regimen.
- Subjects who are currently enrolled in another clinical investigation or have been enrolled in an acne trial within a period of 30 days prior to enrollment in this study.
- Subjects who are pregnant or nursing.
- Subjects who require electrolysis, waxing, or depilatories on the face during conduct of the study.
- Subjects viewed by the investigator as not being able to complete the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Benzoyl Peroxide
Benzoyl Peroxide (BP) 2.5%
|
Benzoyl Peroxide 2.5%
|
Active Comparator: Benzoyl Peroxide plus moisturizing lotion
Benzyol Peroxide 2.5% plus moisturizing lotion
|
Benzoyl Peroxide 2.5%
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subject Reported Change From Baseline Scale
Time Frame: baseline and 1 month
|
-1=worse 0=unchanged
|
baseline and 1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
January 1, 2008
Study Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
November 13, 2007
First Submitted That Met QC Criteria
November 13, 2007
First Posted (Estimate)
November 15, 2007
Study Record Updates
Last Update Posted (Actual)
September 26, 2017
Last Update Submitted That Met QC Criteria
August 28, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU1884
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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