Adherence to Study Medication Compared to Generic Topical Clindamycin Plus Generic Topical Tretinoin in Subjects With Mild to Moderate Acne Vulgaris

Wake Forest University (WFU)

Status and phase: Completed; Phase 4

Conditions: Acne Vulgaris

Treatments: Drug: clindamycin 1% gel; Drug: tretinoin 0.025% cream; Drug: clindamycin phosphate 1.2% and tretinoin 0.025%

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01047189

IRB00007137

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

1

Experimental group

Description:

Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks

Treatment:

Drug: clindamycin phosphate 1.2% and tretinoin 0.025%

2

Active Comparator group

Description:

Generic clindamycin 1% gel plus tretinoin 0.025% cream

Treatment:

Drug: tretinoin 0.025% cream

Drug: clindamycin 1% gel