Status:
COMPLETED
Comparative Antimicrobial Efficacy of Two Topical Acne Therapies for the Treatment of Facial Acne
Lead Sponsor:
Stiefel, a GSK Company
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Acne
Eligibility:
All Genders
12+ years
Phase:
PHASE4
Brief Summary
The purpose of the study is to determine the development of microbial resistance when using one of two topical acne therapies for the treatment of facial acne vulgaris.
Detailed Description
To investigate the development of microbial resistance when using one of two topical acne therapies for the treatment of moderate to moderately severe facial acne vulgaris. Clinical efficacy and toler...
Eligibility Criteria
Inclusion
- Outpatient at least 12 years of age. Female subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study.
- Mild to moderate facial acne vulgaris
- Able to understand the requirements of the study and sign informed consent/HIPAA authorization forms. Subjects under the legal age of consent in the state where the study is conducted must also have the written, informed consent of a parent or legal guardian.
Exclusion
- Female subjects who are pregnant (positive urine pregnancy test), breast feeding or who are of childbearing potential and not practicing a reliable method of birth control
- Allergy or sensitivity to any component of the test medication
- Known hypersensitivity to to any component of the investigational formulations
- Known history of enteritis (regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis
- Beards or sideburns
- Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris
- Evidence of recent alcohol or drug abuse
- Participation in an investigational drug study within 30 days of the baseline visit
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00841776
Start Date
August 1 2007
End Date
January 1 2009
Last Update
May 25 2017
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Dermatology Specialists, PSC
Louisville, Kentucky, United States, 40202
2
Skin We Care Dermatology
Mason, Ohio, United States, 45040