Study of Benzoyl Peroxide Cream for Mild to Moderate Acne Vulgaris
|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.|
|ClinicalTrials.gov Identifier: NCT00558831|
Recruitment Status : Completed
First Posted : November 15, 2007
Results First Posted : November 22, 2010
Last Update Posted : September 26, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris||Drug: Benzoyl Peroxide Drug: Moisturizing Lotion||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||January 2008|
Active Comparator: Benzoyl Peroxide
Benzoyl Peroxide (BP) 2.5%
Drug: Benzoyl Peroxide
Benzoyl Peroxide 2.5%
Active Comparator: Benzoyl Peroxide plus moisturizing lotion
Benzyol Peroxide 2.5% plus moisturizing lotion
Drug: Benzoyl Peroxide
Benzoyl Peroxide 2.5%
Drug: Moisturizing Lotion
- Subject Reported Change From Baseline Scale [ Time Frame: baseline and 1 month ]
- 1=mild improvement
- 2=moderate improvement
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|Ages Eligible for Study:||18 Years to 35 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00558831
|United States, Illinois|
|Northwestern University Department of Dermatology|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Amy Paller, MD||Northwestern University|
|Responsible Party:||Amy Paller, Principle Investigator, Northwestern University|
|Other Study ID Numbers:||
|First Posted:||November 15, 2007 Key Record Dates|
|Results First Posted:||November 22, 2010|
|Last Update Posted:||September 26, 2017|
|Last Verified:||August 2017|
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