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

NCT01047189 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB00007137
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Keywords

Mild to moderate acne vulgaris

Outcome Measures

Primary Outcomes (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

  Percentage of prescribed doses taken as measured by a Medication Event Monitoring System (MEMS) cap

  12 weeks

Secondary Outcomes (1)

• The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count

  Baseline to 12 weeks

Study Arms (2)

1

EXPERIMENTAL

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%

2

ACTIVE COMPARATOR

Generic clindamycin 1% gel plus tretinoin 0.025% cream

Drug: clindamycin 1% gel; Drug: tretinoin 0.025% cream

Interventions

clindamycin phosphate 1.2% and tretinoin 0.025% DRUG

applied once daily for 12 weeks

Also known as: Ziana

1

clindamycin 1% gel DRUG

Topical clindamycin applied each morning for 12 weeks

2

tretinoin 0.025% cream DRUG

Tretinoin 0.025% cream each evening for 12 weeks

2

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University: lead
• Medicis Pharmaceutical Corporation: collaborator

Study Sites (1)

Wake Forest University Health Sciences, Dermatology

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

clindamycin phosphate; clindamycin, tretinoin drug combination; Clindamycin; Gels; Tretinoin

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Results Point of Contact

• Title: Steven Feldman, MD, PhD
• Organization: Wake Forest University Health Sciences

sfeldman@wfubmc.edu

336-716-3775

Study Officials

• Steven R Feldman, MD, Ph.D

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2010
• First Posted: January 12, 2010
• Study Start: March 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: September 10, 2018
• Results First Posted: October 17, 2011

Record last verified: 2018-08

Locations

US (1)