Phase IV Study to Gather More Information About the Safety of ACZONE Gel, 5% in Treating Subjects With Acne Who Have G6PD Deficiency

Acne Vulgaris Clinical Trial

Official title:

ACZ ACN 01. A Phase 4, Double-Blind, Multicenter, Randomized, Vehicle-Controlled, Cross-Over Study to Further Evaluate the Risk of Hematological Adverse Events in G6PD-Deficient Subjects With Acne Vulgaris Treated With ACZONE™ (Dapsone) Gel, 5%.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00243542
• Other study ID #: ACZ ACN 01
• Status: Completed
• Phase: Phase 4
• First received: October 21, 2005
• Last updated: May 27, 2011
• Start date: November 2005
• Est. completion date: October 2006

Study information

• Verified date: May 2011
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to gather more information about the safety of ACZONE Gel, 5% in treating subjects with acne who have certain blood disorders.

ACZONE Gel, 5% is a prescription skin use (topical) medicine used to help treat acne in people 12 years and older. ACZONE Gel, 5% has been studied in approximately 4000 people and was shown to reduce the number of pimples and improve acne.

The active drug ingredient in ACZONE Gel, 5% is dapsone. People with blood disorders called "G6PD deficiency", "methemoglobin reductase deficiency", and "hemoglobin M" have a higher chance of side effects with dapsone.

G6PD is short for "glucose-6-phosphate dehydrogenase". It is an enzyme found in red blood cells, which carry oxygen to all parts of the body. G6PD helps the red blood cells to function normally. Some people have less G6PD in their red blood cells than the average person. This is called G6PD deficiency.

Two treatments - ACZONE Gel, 5% and placebo - will be studied for comparison.

Description:

Study Objectives:

• To compare the safety profile and risk of hemolysis of ACZONE Gel, 5% to that of the vehicle after 12 weeks each of twice daily applications in acne vulgaris subjects with glucose-6-phosphate-dehydrogenase (G6PD) deficiency.

• To determine the systemic levels of plasma dapsone and N-acetyl dapsone during treatment with ACZONE Gel, 5%.

Study Population:

Approximately 60 male and female subjects

Study Treatment:

All subjects in the study will receive ACZONE Gel, 5% and vehicle in 1 of 2 sequences; each for a 12-week period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

To be eligible for this study, subjects must fulfill all of the following criteria:

1. Male or female =12 years of age.

2. A clear diagnosis of acne vulgaris, defined as =20 acne inflammatory and/or non-inflammatory lesions (=10 of the acne lesions must be on the face, the others may be present on the neck, shoulders, upper chest, and upper back) at screening.

3. A diagnosis of G6PD deficiency, defined as having a G6PD value below the lower limit of normal for the central reference laboratory.

Exclusion Criteria:

Subjects meeting any of the following criteria will be excluded from the study:

1. A dermal examination reveals the presence of severe cystic acne or acne conglobata.

2. Treatment with isotretinoin (Accutane®) within 3 months of baseline and throughout the study.

3. Subjects predisposed to anemia for other medical reasons, including but not limited to gastrointestinal bleeding and cancer.

4. Subjects who are using topical or systemic medications for acne throughout the study. This includes, but is not limited to, benzoyl peroxide, antibiotics, topical Vitamin A derivatives such as Retin-A.

5. Subjects who are using medication or eating foods that could potentially cause a hemolytic event in individuals with G6PD deficiency during the study.

6. Facial surgery (dermabrasion, laser resurfacing or other facial cosmetic surgeries) within 3 months of baseline and throughout the study.

7. A history of hypersensitivity to dapsone, parabens, or any component of the study products.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• ACZONE Gel, 5%

• Vehicle

Locations

Country	Name	City	State
United States	DermResearch, Inc.	Austin	Texas
United States	Okatie Research Center, LLC	Beaufort	South Carolina
United States	DiscoveResearch, Inc.	Beaumont	Texas
United States	Radiant Research, Inc.	Birmingham	Alabama
United States	Boston Clinical Trials	Boston	Massachusetts
United States	Department of Dermatology SUNY Downstate Medical Center	Brooklyn	New York
United States	J&S Studies, Inc.	Bryan	Texas
United States	Metrolina Medical Research	Charlotte	North Carolina
United States	Universtiy Dermatology Consultants, Inc.	Cincinnati	Ohio
United States	Research Across America	Dallas	Texas
United States	Henry Ford Medical Center - New Center One	Detroit	Michigan
United States	Suzanne Bruce and Associates, PA	Houston	Texas
United States	Dermatology Associates of Knoxville	Knoxville	Tennessee
United States	The Education and Research Foundation, Inc.	Lynchburg	Virginia
United States	FXM Research	Miami	Florida
United States	Advanced Healthcare, SC	Milwaukee	Wisconsin
United States	Dermatology Research Associates	Nashville	Tennessee
United States	Columbia University Medical Center Department of Dermatology	New York	New York
United States	MedaPhase, Inc.	Newnan	Georgia
United States	Virginia Clinical Research	Norfolk	Virginia
United States	Skin Specialists, PC	Omaha	Nebraska
United States	University Clinical Research, Inc	Pembroke Pines	Florida
United States	Paddington Testing Clinic	Philadelphia	Pennsylvania
United States	Society Hill Dermatology	Philadelphia	Pennsylvania
United States	Therapeutics Clinical Research	San Diego	California
United States	Department of Dermatology, University of California, San Francisco	San Francisco	California
United States	Washington University Dermatology Clinical Trials Unit	St. Louis	Missouri
United States	Dermatology Associates, PC at the Washington Hospital Center	Washington	District of Columbia
United States	Howard University Hospital Department of Dermatology	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The within-subject between treatment period differences in change from baseline to the 2nd week of each treatment period and change from baseline to the end of each treatment period will be summarized based upon various lab parameters.
Primary	The safety evaluable data set will be used, and each variable will be summarized using descriptive statistics.
Primary	Analyses of clinical lab values, AEs, vitals, and concomitant meds will be performed on all subjects who received treatment.
Secondary	Acne Lesions: Tabular summaries of total lesion counts will be provided by appropriate descriptive statistics.