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

NCT ID: NCT01047189

Last Updated: 2018-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2009-10-31

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

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

Group Type: EXPERIMENTAL

clindamycin phosphate 1.2% and tretinoin 0.025%

Intervention Type: DRUG

applied once daily for 12 weeks

2

Generic clindamycin 1% gel plus tretinoin 0.025% cream

Group Type: ACTIVE_COMPARATOR

clindamycin 1% gel

Intervention Type: DRUG

Topical clindamycin applied each morning for 12 weeks

tretinoin 0.025% cream

Intervention Type: DRUG

Tretinoin 0.025% cream each evening for 12 weeks

Interventions

clindamycin phosphate 1.2% and tretinoin 0.025%

applied once daily for 12 weeks

Intervention Type: DRUG

clindamycin 1% gel

Topical clindamycin applied each morning for 12 weeks

Intervention Type: DRUG

tretinoin 0.025% cream

Tretinoin 0.025% cream each evening for 12 weeks

Intervention Type: DRUG

Other Intervention Names

Ziana

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medicis Pharmaceutical Corporation

INDUSTRY

Sponsor Role: collaborator

Wake Forest University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven R Feldman, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences, Dermatology

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

IRB00007137

Identifier Type: -

Identifier Source: org_study_id