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
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: 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
Facial Dermatoses
Sebaceous Gland Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014