Comparative Antimicrobial Efficacy of Two Topical Acne Therapies for the Treatment of Facial Acne

Phase 4

Completed

• Conditions: Acne
• Interventions: Drug: Ziana gel; Drug: Duac

• Registration Number: NCT00841776
• Lead Sponsor: Stiefel, a GSK Company

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 tolerability will be assessed.

Study Timeline

• Study Start: 2007-08
• Primary Completion: 2008-11
• Study Completion: 2009-01
• Study First Submitted: 2009-02-10
• Study First Submitted QC: 2009-02-10
• Study First Posted: 2009-02-11
• Results First Submitted: 2010-04-07
• Results First Submitted QC: 2010-06-29
• Results First Posted: 2010-07-23
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-24
• Last Update Posted: 2017-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ziana gel	Ziana gel	Clindamycin and tretinoin gel
Duac gel	Duac	Clindamycin and benzoyl peroxide gel

Primary Outcome Measures

Name	Time	Method
Median Change in Total Propionibacterium Acne (P.Acne) Counts	Baseline, Weeks 2, 4, 8, 12, & 16	Median change in total colony forming units of propionibacterium acne (P.acne) will be counted.

Secondary Outcome Measures

Name	Time	Method
Median Change in Clindamycin Resistant P. Acne.	Baseline, Weeks 2, 4, 8, 12, 16	Median change in total colony forming units of clindamycin resistant p. acne.
Median Change in Erythromycin-resistant P. Acne Counts	Baseline, Weeks 2, 4, 8, 12, and 16	Total colony forming units of erythromycin-resistant p. acnes.
Median Change in Total Acne Lesions	Baseline, Weeks 2, 4, 8, 12, and 16	Median Change in Total Acne Lesions
Median Change in Inflammatory Acne Lesion Counts	Baseline, Weeks 2, 4, 8, 12, and 16	Median Change in Inflammatory Acne Lesion Counts
Median Change in Noninflammaotry Acne Counts	Baseline, Weeks 2, 4, 8, 12, and 16	Median Change in Noninflammaotry Acne Counts

Trial Locations

Locations (2)

Skin We Care Dermatology; 🇺🇸 Mason, Ohio, United States

Dermatology Specialists, PSC; 🇺🇸 Louisville, Kentucky, United States