Comparative Antimicrobial Efficacy of Two Topical Acne Therapies for the Treatment of Facial Acne
May 24, 2017 updated by: Stiefel, a GSK Company
Comparative Antimicrobial Efficacy of Two Topical Acne Therapies for the Treatment of Moderate to Moderately Severe Facial Acne Vulgaris
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
54
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kentucky
-
Louisville, Kentucky, United States, 40202
- Dermatology Specialists, PSC
-
-
Ohio
-
Mason, Ohio, United States, 45040
- Skin We Care Dermatology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Duac gel
Clindamycin and benzoyl peroxide gel
|
Clindamycon and benzoyl peroxide topical gel once a day for 12 weeks
|
|
Active Comparator: Ziana gel
Clindamycin and tretinoin gel
|
Clindamycin and tretinoin gel once a day for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Median Change in Total Propionibacterium Acne (P.Acne) Counts
Time Frame: Baseline, Weeks 2, 4, 8, 12, & 16
|
Median change in total colony forming units of propionibacterium acne (P.acne) will be counted.
|
Baseline, Weeks 2, 4, 8, 12, & 16
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Median Change in Clindamycin Resistant P. Acne.
Time Frame: Baseline, Weeks 2, 4, 8, 12, 16
|
Median change in total colony forming units of clindamycin resistant p. acne.
|
Baseline, Weeks 2, 4, 8, 12, 16
|
|
Median Change in Erythromycin-resistant P. Acne Counts
Time Frame: Baseline, Weeks 2, 4, 8, 12, and 16
|
Total colony forming units of erythromycin-resistant p. acnes.
|
Baseline, Weeks 2, 4, 8, 12, and 16
|
|
Median Change in Total Acne Lesions
Time Frame: Baseline, Weeks 2, 4, 8, 12, and 16
|
Median Change in Total Acne Lesions
|
Baseline, Weeks 2, 4, 8, 12, and 16
|
|
Median Change in Inflammatory Acne Lesion Counts
Time Frame: Baseline, Weeks 2, 4, 8, 12, and 16
|
Median Change in Inflammatory Acne Lesion Counts
|
Baseline, Weeks 2, 4, 8, 12, and 16
|
|
Median Change in Noninflammaotry Acne Counts
Time Frame: Baseline, Weeks 2, 4, 8, 12, and 16
|
Median Change in Noninflammaotry Acne Counts
|
Baseline, Weeks 2, 4, 8, 12, and 16
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
November 1, 2008
Study Completion (Actual)
January 1, 2009
Study Registration Dates
First Submitted
February 10, 2009
First Submitted That Met QC Criteria
February 10, 2009
First Posted (Estimate)
February 11, 2009
Study Record Updates
Last Update Posted (Actual)
May 25, 2017
Last Update Submitted That Met QC Criteria
May 24, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DTG0703
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.