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

• ClinicalTrials.gov Identifier: NCT01047189
• Recruitment Status: Completed
• First Posted: January 12, 2010
• Results First Posted: October 17, 2011
• Last Update Posted: September 10, 2018
• Sponsor: Wake Forest University
• Collaborator: Medicis Pharmaceutical Corporation
• Information provided by (Responsible Party): Wake Forest University Health Sciences ( Wake Forest University )

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acne Vulgaris	Drug: clindamycin phosphate 1.2% and tretinoin 0.025%; Drug: clindamycin 1% gel; Drug: tretinoin 0.025% cream	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• 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 Start Date: March 2009
• Actual Primary Completion Date: October 2009
• Actual Study Completion Date: October 2009

Arms and Interventions

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 Name: 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

Outcome Measures

Primary Outcome Measures :

1. 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 [ Time Frame: 12 weeks ]
   Percentage of prescribed doses taken as measured by a Medication Event Monitoring System (MEMS) cap

Secondary Outcome Measures :

1. The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count [ Time Frame: Baseline to 12 weeks ]

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United States, North Carolina

Wake Forest University Health Sciences, Dermatology

Winston-Salem, North Carolina, United States, 27157

Sponsors and Collaborators

Wake Forest University

Medicis Pharmaceutical Corporation

Investigators

• Principal Investigator: Steven R Feldman, MD, Ph.D; Wake Forest University Health Sciences

More Information

• Responsible Party: Wake Forest University
• ClinicalTrials.gov Identifier: NCT01047189
• Other Study ID Numbers: IRB00007137
• First Posted: January 12, 2010
• Results First Posted: October 17, 2011
• Last Update Posted: September 10, 2018
• Last Verified: August 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):

Mild to moderate acne vulgaris

Additional relevant MeSH terms:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Tretinoin; Anti-Bacterial Agents; Anti-Infective Agents; Protein Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Keratolytic Agents; Dermatologic Agents