DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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


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


Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Males or Females 12 years of age or older with a diagnosis of mild to moderate acne


- 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


- 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


- Crohns disease, ulcerative colitis, or have developed colitis with past antibiotic


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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017