Comparative Antimicrobial Efficacy of Two Topical Acne Therapies for the Treatment of Facial Acne
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acne
Intervention: Duac (Drug); Ziana gel (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Stiefel, a GSK Company Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
Official title: Comparative Antimicrobial Efficacy of Two Topical Acne Therapies for the Treatment of Moderate to Moderately Severe Facial Acne Vulgaris
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Median Change in Total Propionibacterium Acne (P.Acne) Counts
Secondary outcome: Median Change in Clindamycin Resistant P. Acne.Median Change in Erythromycin-resistant P. Acne Counts Median Change in Total Acne Lesions Median Change in Inflammatory Acne Lesion Counts Median Change in Noninflammaotry Acne Counts
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 tolerability will be assessed.
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Dermatology Specialists, PSC, Louisville, Kentucky 40202, United States
Skin We Care Dermatology, Mason, Ohio 45040, United States
Additional Information
Starting date: August 2007
Last updated: July 12, 2011
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