Comparing OTC Acne Treatment to Prescription Regimen

This study has been completed.
Sponsor:
Collaborator:
Loreal USA
Information provided by (Responsible Party):
Amy Longenecker, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01237821
First received: November 9, 2010
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

This research is being done to find out the safety and efficacy of two acne creams, Effaclar and Benzaclin when used twice daily with a topical retinoid. Effaclar and Benzaclin are FDA approved for the treatment of acne.


Condition Intervention
Acne Vulgaris
Drug: BenzaClin
Drug: Effaclar

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A MULTI-CENTER, DOUBLE-BLIND CLINICAL TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF TWO ACNE CREAMS IN SUBJECTS WITH MILD TO MODERATE ACNE VULGARIS

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Acne [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    A multi-center, double-blind clinical trial to evaluate the safety and efficacy of two acne creams in subjects with mild to moderate acne vulgaris


Enrollment: 80
Study Start Date: October 2010
Study Completion Date: October 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BenzaClin
Evaluate and compare tolerance and efficacy of two anti-acne creams, Effaclar and Benzaclin over a twelve week period.Inclusion- males and females ages 18-50, mild to moderate acne vulgaris with > or equal to 15 inflammatory lesions, > or equal to 20 non-inflammatory lesions, avoid excessive sun exposure or tanning beds throughout the study, . Exclusion- Participants who have another skin condition that will interfere with lesion counting or assessments
Drug: BenzaClin
Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Active Comparator: effaclar
Evaluate and compare tolerance and efficacy of two anti-acne creams, Effaclar and Benzaclin over a twelve week period.Inclusion- males and females ages 18-50, mild to moderate acne vulgaris with > or equal to 15 inflammatory lesions, > or equal to 20 non-inflammatory lesions, avoid excessive sun exposure or tanning beds throughout the study, . Exclusion- Participants who have another skin condition that will interfere with lesion counting or assessments
Drug: Effaclar
Topical, Bid, 12 weeks

Detailed Description:

There are many products on the market to treat facial acne. The medication that this study will be evaluating, Benzaclin and Retin-A have been approved by the FDA and is available by prescription, Effaclar is an over the counter product. This study will hopefully recognize a treatment combination that is effective in reducing acne vulgaris in adults 18-50.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:males and females ages 18-50, mild to moderate acne vulgaris with > or equal to 15 inflammatory lesions, > or equal to 20 non-inflammatory lesions, avoid excessive sun exposure or tanning beds throughout the study

Exclusion Criteria:Participants who have another skin condition that will interfere with lesion counting or assessments

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01237821

Locations
United States, Pennsylvania
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Loreal USA
Investigators
Study Director: Christian Oresajo, PhD Loreal USA
  More Information

No publications provided

Responsible Party: Amy Longenecker, RN, CCRC, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01237821     History of Changes
Other Study ID Numbers: CS1007033A
Study First Received: November 9, 2010
Last Updated: March 24, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases

ClinicalTrials.gov processed this record on April 23, 2014