Adherence to Study Medication Compared to Generic Topical Clindamycin Plus Generic Topical Tretinoin in Subjects With Mild to Moderate Acne Vulgaris
Information source: Wake Forest School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acne Vulgaris
Intervention: clindamycin phosphate 1.2% and tretinoin 0.025% (Drug); clindamycin 1% gel (Drug); tretinoin 0.025% cream (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Wake Forest School of Medicine Official(s) and/or principal investigator(s): Steven R Feldman, MD, Ph.D, Principal Investigator, Affiliation: Wake Forest School of Medicine
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: 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
Secondary outcome: The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Wake Forest University Health Sciences, Dermatology, Winston-Salem, North Carolina 27157, United States
Additional Information
Starting date: March 2009
Last updated: November 9, 2011
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