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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01047189
• Other study ID #: IRB00007137
• Status: Completed
• Phase: Phase 4
• Start date: March 2009
• Est. completion date: October 2009

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• clindamycin phosphate 1.2% and tretinoin 0.025%
applied once daily for 12 weeks
• clindamycin 1% gel
Topical clindamycin applied each morning for 12 weeks
• tretinoin 0.025% cream
Tretinoin 0.025% cream each evening for 12 weeks

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences, Dermatology	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University	Medicis Pharmaceutical Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of prescribed doses taken as measured by a Medication Event Monitoring System (MEMS) cap	12 weeks
Secondary	The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count		Baseline to 12 weeks