Study of Benzoyl Peroxide Cream for Mild to Moderate Acne Vulgaris

This study has been completed.
Sponsor:
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00558831
First received: November 13, 2007
Last updated: January 12, 2011
Last verified: January 2011
  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.


Condition Intervention
Acne Vulgaris
Drug: Benzoyl Peroxide
Drug: Moisturizing Lotion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Subject Reported Change From Baseline Scale [ Time Frame: baseline and 1 month ] [ Designated as safety issue: No ]

    -1=worse 0=unchanged

    • 1=mild improvement
    • 2=moderate improvement
    • 3=clear


Enrollment: 11
Study Start Date: October 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Benzoyl Peroxide
Benzoyl Peroxide 2.5%
Drug: Benzoyl Peroxide
Benzoyl Peroxide 2.5%
Active Comparator: Benzoyl Peroxide plus moisturizing lotion
Benzoyl Peroxide 2.5% plus moisturizing lotion
Drug: Benzoyl Peroxide
Benzoyl Peroxide 2.5%
Drug: Moisturizing Lotion

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00558831

Locations
United States, Illinois
Northwestern University Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Amy Paller, MD Northwestern University
  More Information

No publications provided

Responsible Party: Amy Paller, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00558831     History of Changes
Other Study ID Numbers: STU1884
Study First Received: November 13, 2007
Results First Received: October 12, 2010
Last Updated: January 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Acne

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Facial Dermatoses
Sebaceous Gland Diseases
Skin Diseases
Benzoyl Peroxide
Emollients
Dermatologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014