Expired Study
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Chicago, Illinois 60611


Purpose:

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 summary:

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.


Criteria:

Inclusion Criteria: 1. Healthy male or female subjects who are 18 to 35 years of age. 2. Subjects are in good health and are free of any other facial skin disorders that may interfere with acne study assessments. 3. 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. 4. 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. 5. 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. 6. 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. 7. 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. 8. Subjects who agree not to change facial cosmetic products during the study. 9. Subjects who agree to only use sunscreen/sunblock agents that are labeled as non-comedogenic. Exclusion Criteria: 1. Subjects or parents of subjects who are unable to understand the protocol or to give informed consent/assent. 2. Subjects with mental illness. 3. Subjects with no inflammatory acne. 4. Subjects with any acne cysts or nodules. 5. Subjects with acne conglobata, acne fulminans, secondary acne (e.g. Chloracne, drug-induced acne), or any acne requiring systemic treatment. 6. Subjects with excessive facial hair that may interfere with study assessments. 7. Subjects with other facial skin disorders that may interfere with study assessments. 8. Subjects with a history of skin cancer or actinic keratosis. 9. Subjects who have used tanning devices within one week prior to baseline study visit. 10. 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. 11. Use of hormonal oral contraceptives for acne control or for less than 6 months prior to study baseline. 12. Subjects with known allergies, a history of, or sensitive to salicylic acid, benzoyl peroxide or any of the test article components. 13. 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. 14. 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. 15. Subjects who are pregnant or nursing. 16. Subjects who require electrolysis, waxing, or depilatories on the face during conduct of the study. 17. Subjects viewed by the investigator as not being able to complete the study.


Study is Available At:


Original ID:

STU1884


NCT ID:

NCT00558831


Secondary ID:


Study Acronym:


Brief Title:

Study of Benzoyl Peroxide Cream for Mild to Moderate Acne Vulgaris


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

35 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Northwestern University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

11


Enrollment Type:

Actual


Overall Contact Information

Official Name:Amy Paller, MD
Principal Investigator
Northwestern University

Study Dates

Start Date:October 2007
Completion Date:January 2008
Completion Type:Actual
Primary Completion Date:January 2008
Primary Completion Type:Actual
Verification Date:August 2017
Last Changed Date:August 28, 2017
First Received Date:November 13, 2007
First Results Date:October 12, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:Subject Reported Change From Baseline Scale
Time Frame:baseline and 1 month
Safety Issues:False
Description:-1=worse 0=unchanged 1=mild improvement 2=moderate improvement 3=clear

Study Interventions

Intervention Type:Drug
Name:Benzoyl Peroxide
Description:Benzoyl Peroxide 2.5%
Arm Name:Benzoyl Peroxide
Intervention Type:Drug
Name:Moisturizing Lotion
Arm Name:Benzoyl Peroxide plus moisturizing lotion

Study Arms

Study Arm Type:Active Comparator
Arm Name:Benzoyl Peroxide plus moisturizing lotion
Description:Benzyol Peroxide 2.5% plus moisturizing lotion
Study Arm Type:Active Comparator
Arm Name:Benzoyl Peroxide
Description:Benzoyl Peroxide (BP) 2.5%

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Northwestern University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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