Comparing OTC Acne Treatment to Prescription Regimen - Full Text View

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:

MedlinePlus related topics: Acne

Drug Information available for: Benzoyl peroxide, clindamycin drug combination

U.S. FDA Resources

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

Estimated Enrollment:	80
Study Start Date:	October 2010
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	February 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 egual 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 egual 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

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 egual 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 egual 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 egual 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

Contacts

Contact: Amy L Longenecker, LPN, CCRC	717-531-1513	alongenecker@psu.edu
Contact: LeRoy Tanner, LPN	717-531-4439	ltanner@hmc.psu.edu

Locations

United States, Pennsylvania
Penn State Hershey Medical Center	Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Amy Longenecker 717-531-1513
Principal Investigator: Diane M Thiboutot, md

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:	Christian Oresajo, PhD, L'Oreal, USA
ClinicalTrials.gov Identifier:	NCT01237821 History of Changes
Other Study ID Numbers:	CS1007033A
Study First Received:	November 9, 2010
Last Updated:	November 9, 2010
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 May 16, 2013