Back to resultsAdherence to Study Medication Compared to Generic Topical Clindamycin Plus Generic Topical Tretinoin in Subjects With Mild to Moderate Acne Vulgaris
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
clindamycin phosphate 1.2% and tretinoin 0.025%
clindamycin 1% gel
tretinoin 0.025% cream
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring Mild to moderate acne vulgaris
Eligibility Criteria
Inclusion Criteria:
- Males or Females 12 years of age or older with a diagnosis of mild to moderate acne vulgaris.
- Subjects must sign written informed consent and agree to come for all study visits.
Exclusion Criteria:
- Use of experimental drugs within 1 month prior to initiation of study therapy.
- Pregnant and nursing females will not be allowed in the study, and females of childbearing potential will have a pregnancy test at baseline. Females of childbearing potential must agree to use approved birth control methods for the duration of the study.
- Use of systemic retinoids within 2 months of enrollment, use of any topical retinoids, systemic antibiotics, nicotinamide, systemic steroids or any other medication that may confound the results of the study within 1 month prior to start of the study
- Use of any other topical medications for acne, including cosmetics containing retinol, within 2 weeks prior to study entry.
- Any skin condition or disease that may require concurrent therapy or may confound the evaluation;
- History of hypersensitivity to any of the formulation components;
- Facial skin cancer or facial actinic keratosis;
- Use of any photosensitizing agents.
- Use of isotretinoin within the last 6 months.
- Chemical peels, microdermabrasion or laser resurfacing within 3 months of study entry.
- Crohns disease, ulcerative colitis, or have developed colitis with past antibiotic use.
Sites / Locations
- Wake Forest University Health Sciences, Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
Generic clindamycin 1% gel plus tretinoin 0.025% cream
Outcomes
Primary Outcome Measures
Measured Adherence to ZIANA Gel or Generic Topical Clindamycin 1% Gel Each Morning Plus Generic Topical Tretinoin 0.025% Cream Each Evening in Subjects With Mild to Moderate Acne
Percentage of prescribed doses taken as measured by a Medication Event Monitoring System (MEMS) cap
Secondary Outcome Measures
The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count
Full Information
NCT ID
NCT01047189
First Posted
January 11, 2010
Last Updated
August 9, 2018
Sponsor
Wake Forest University
Collaborators
Medicis Pharmaceutical Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01047189
Brief Title
Adherence to Study Medication Compared to Generic Topical Clindamycin Plus Generic Topical Tretinoin in Subjects With Mild to Moderate Acne Vulgaris
Official Title
Adherence to ZIANA (Clindamycin Phosphate 1.2% With Tretinoin 0.025%)Gel Compared to Generic Topical Clindamycin Plus Generic Topical Tretinoin in Subjects With Mild to Moderate Acne Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University
Collaborators
Medicis Pharmaceutical Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research study is to evaluate the effectiveness of two different types of topical acne medication. This study will help to determine if one combined medication results in better acne improvement than two separate medications for acne.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Mild to moderate acne vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
Arm Title
2
Arm Type
Active Comparator
Arm Description
Generic clindamycin 1% gel plus tretinoin 0.025% cream
Intervention Type
Drug
Intervention Name(s)
clindamycin phosphate 1.2% and tretinoin 0.025%
Other Intervention Name(s)
Ziana
Intervention Description
applied once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
clindamycin 1% gel
Intervention Description
Topical clindamycin applied each morning for 12 weeks
Intervention Type
Drug
Intervention Name(s)
tretinoin 0.025% cream
Intervention Description
Tretinoin 0.025% cream each evening for 12 weeks
Primary Outcome Measure Information:
Title
Measured Adherence to ZIANA Gel or Generic Topical Clindamycin 1% Gel Each Morning Plus Generic Topical Tretinoin 0.025% Cream Each Evening in Subjects With Mild to Moderate Acne
Description
Percentage of prescribed doses taken as measured by a Medication Event Monitoring System (MEMS) cap
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count
Time Frame
Baseline to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males or Females 12 years of age or older with a diagnosis of mild to moderate acne vulgaris.
Subjects must sign written informed consent and agree to come for all study visits.
Exclusion Criteria:
Use of experimental drugs within 1 month prior to initiation of study therapy.
Pregnant and nursing females will not be allowed in the study, and females of childbearing potential will have a pregnancy test at baseline. Females of childbearing potential must agree to use approved birth control methods for the duration of the study.
Use of systemic retinoids within 2 months of enrollment, use of any topical retinoids, systemic antibiotics, nicotinamide, systemic steroids or any other medication that may confound the results of the study within 1 month prior to start of the study
Use of any other topical medications for acne, including cosmetics containing retinol, within 2 weeks prior to study entry.
Any skin condition or disease that may require concurrent therapy or may confound the evaluation;
History of hypersensitivity to any of the formulation components;
Facial skin cancer or facial actinic keratosis;
Use of any photosensitizing agents.
Use of isotretinoin within the last 6 months.
Chemical peels, microdermabrasion or laser resurfacing within 3 months of study entry.
Crohns disease, ulcerative colitis, or have developed colitis with past antibiotic use.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven R Feldman, MD, Ph.D
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences, Dermatology
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Adherence to Study Medication Compared to Generic Topical Clindamycin Plus Generic Topical Tretinoin in Subjects With Mild to Moderate Acne Vulgaris
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