Clinical trial NCT01047189: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Keywords: Mild to moderate acne vulgaris
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Medicis Pharmaceutical Corporation
First posted: 2010-01-12
Enrollment: 26
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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
timeFrame: 12 weeks
Secondary outcomes:
measure: The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences, Dermatology
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Steven R Feldman, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: