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Comparing OTC Acne Treatment to Prescription Regimen

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01237821
First Posted: November 10, 2010
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Loreal USA
Information provided by (Responsible Party):
Amy Longenecker, Milton S. Hershey Medical Center
November 9, 2010
November 10, 2010
October 12, 2017
October 2010
August 2011   (Final data collection date for primary outcome measure)
Acne [ Time Frame: 16 weeks ]
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
Same as current
Complete list of historical versions of study NCT01237821 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Comparing OTC Acne Treatment to Prescription Regimen
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
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acne Vulgaris
  • Drug: BenzaClin
    Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
  • Drug: Effaclar
    Topical, Bid, 12 weeks
  • 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
    Intervention: Drug: BenzaClin
  • 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
    Intervention: Drug: Effaclar
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
October 2011
August 2011   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01237821
CS1007033A
No
Not Provided
Not Provided
Amy Longenecker, Milton S. Hershey Medical Center
Milton S. Hershey Medical Center
Loreal USA
Study Director: Christian Oresajo, PhD Loreal USA
Milton S. Hershey Medical Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP