- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00787943
Study of Two Different 10.0% Benzoyl Peroxide Creams for Mild to Moderate Acne Vulgaris
A Split-face, Paired-comparison, Pilot Study to Evaluate Safety and Efficacy of Two Topical Benzoyl Peroxide 10.0% Creams for Mild to Moderate Acne Vulgaris
Study Overview
Status
Conditions
Detailed Description
Acne vulgaris is a follicular disorder occurring in pilosebaceous units in the skin of the face, neck, and upper trunk. These sebaceous follicles have follicular channels and adjacent multiacinar sebaceous glands. In the lubrication process of normal skin, sebum travels through the follicular canal to the skin surface, carrying along with it desquamated cells from follicular epithelium. Acne develops when these specialized follicles undergo pathologic alterations that result in the formation of non-inflammatory lesions (comedones) and inflammatory lesions (papules, pustules, and nodules).
The basic cause of acne remains unknown, but its manifestations are thought to be the product of four pathogenic events: 1) increased sebum production fueled by androgenic stimulation in the pubertal period; 2) obstruction of the pilosebaceous unit due to an abnormal keratinization process; 3) proliferation of Propionibacterium acnes, an anaerobic diptheroid normally residing in pilosebaceous follicles; and 4) inflammation that is mediated both by the action of chemotactic factors and various enzymes, and initiated in part by the interaction of P. acnes with toll-like receptors. Impaction of the pilosebaceous follicle gives rise to the microcomedo that is thought to be the precursor lesion of acne.
Topical benzoyl peroxide is a common and well-established agent with known antibacterial and antimicrobial properties used in the treatment of acne vulgaris. The safety profile for topical benzoyl peroxide has been well delineated. The most common side effects attributed to benzoyl peroxide products include irritation, dryness, scaling, burning and stinging.
Benzoyl peroxide 10.0% creams (Formulation #1 and Formulation #2) will be evaluated to detect any differences in their response for safety and efficacy.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Ann & Robert H Lurie Children's Hospital of Chicago
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy male or female subjects who are 13 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 5 inflammatory lesions (papules and pustules) on each side of the face, and a minimum of 5 non-inflammatory lesions (open comedones and closed comedones) on each side of the face. Lesions should be relatively symmetrical in appearance on both sides of the face. At least one inflammatory lesion should be measured no smaller than 2 mm in diameter and should be visible on each side of the face in images taken with digital imaging station.
- 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 to 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 allergy or sensitivity to 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Left side of face
Topical benzoyl peroxide 10.0% cream - Formulation 2 or Topical benzoyl peroxide 10.0% cream - Formulation 1 is to be applied to left side of the face.
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Formulation 1 will be applied to the randomly-assigned single (left or right) side of the face twice daily.
Other Names:
Formulation 1 will be applied to the randomly-assigned single (left or right) side of the face twice daily.
Other Names:
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Experimental: Right side of face
Topical benzoyl peroxide 10.0% cream - Formulation 2 or Topical benzoyl peroxide 10.0% cream - Formulation 1 is to be applied to right side of the face.
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Formulation 1 will be applied to the randomly-assigned single (left or right) side of the face twice daily.
Other Names:
Formulation 1 will be applied to the randomly-assigned single (left or right) side of the face twice daily.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Inflammatory Lesions (Papules and Pustules)
Time Frame: 4 Weeks
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Assessment will be done based on lesion counting.
We will compare the lesions treated twice daily with the benzoyl peroxide 10.0% cream Formulation #1 vs. the benzoyl peroxide 10.0% cream Formulation #2.
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4 Weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AP-032408
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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