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

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

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: clindamycin phosphate 1.2% and tretinoin 0.025%; Drug: clindamycin 1% gel; Drug: tretinoin 0.025% cream

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences, Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks	Drug: clindamycin phosphate 1.2% and tretinoin 0.025%; applied once daily for 12 weeks; Other Names: Ziana
Active Comparator: 2; Generic clindamycin 1% gel plus tretinoin 0.025% cream	Drug: clindamycin 1% gel; Topical clindamycin applied each morning for 12 weeks; Drug: tretinoin 0.025% cream; Tretinoin 0.025% cream each evening for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count	Baseline to 12 weeks

Collaborators and Investigators

• Sponsor: Wake Forest University
• Collaborators: Medicis Pharmaceutical Corporation

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: January 11, 2010
• First Submitted That Met QC Criteria: January 11, 2010
• First Posted (Estimate): January 12, 2010

Study Record Updates

• Last Update Posted (Actual): September 10, 2018
• Last Update Submitted That Met QC Criteria: August 9, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Mild to moderate acne vulgaris
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Dermatologic Agents; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Keratolytic Agents; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Tretinoin
• Other Study ID Numbers: IRB00007137

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No