Clinical trial NCT00243542: Phase IV Study to Gather More Information About the Safety of ACZONE Gel, 5% in Treating Subjects With Acne Who Have G6PD Deficiency
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%.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Keywords: Acne, G6PD deficiency, Dapsone
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2005-10-24
Enrollment: 64
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
measure: The safety evaluable data set will be used, and each variable will be summarized using descriptive statistics.
measure: Analyses of clinical lab values, AEs, vitals, and concomitant meds will be performed on all subjects who received treatment.
Secondary outcomes:
measure: Acne Lesions: Tabular summaries of total lesion counts will be provided by appropriate descriptive statistics.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Radiant Research, Inc.
state: Alabama
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: San Francisco
country: United States
facility: Department of Dermatology, University of California, San Francisco
state: California
city: Washington
country: United States
facility: Dermatology Associates, PC at the Washington Hospital Center
state: District of Columbia
city: Washington
country: United States
facility: Howard University Hospital Department of Dermatology
state: District of Columbia
city: Miami
country: United States
facility: FXM Research
state: Florida
city: Pembroke Pines
country: United States
facility: University Clinical Research, Inc
state: Florida
city: Newnan
country: United States
facility: MedaPhase, Inc.
state: Georgia
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Medical Center - New Center One
state: Michigan
city: St. Louis
country: United States
facility: Washington University Dermatology Clinical Trials Unit
state: Missouri
city: Omaha
country: United States
facility: Skin Specialists, PC
state: Nebraska
city: Brooklyn
country: United States
facility: Department of Dermatology SUNY Downstate Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center Department of Dermatology
state: New York
city: Charlotte
country: United States
facility: Metrolina Medical Research
state: North Carolina
city: Cincinnati
country: United States
facility: Universtiy Dermatology Consultants, Inc.
state: Ohio
city: Philadelphia
country: United States
facility: Paddington Testing Clinic
state: Pennsylvania
city: Philadelphia
country: United States
facility: Society Hill Dermatology
state: Pennsylvania
city: Beaufort
country: United States
facility: Okatie Research Center, LLC
state: South Carolina
city: Knoxville
country: United States
facility: Dermatology Associates of Knoxville
state: Tennessee
city: Nashville
country: United States
facility: Dermatology Research Associates
state: Tennessee
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: Beaumont
country: United States
facility: DiscoveResearch, Inc.
state: Texas
city: Bryan
country: United States
facility: J&S Studies, Inc.
state: Texas
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and Associates, PA
state: Texas
city: Lynchburg
country: United States
facility: The Education and Research Foundation, Inc.
state: Virginia
city: Norfolk
country: United States
facility: Virginia Clinical Research
state: Virginia
city: Milwaukee
country: United States
facility: Advanced Healthcare, SC
state: Wisconsin
Study officials:
affiliation: QLT USA, Inc.
name: Steven Garrett, MS, DDS
role: STUDY_DIRECTOR
References:
citation: Piette WW, Taylor S, Pariser D, Jarratt M, Sheth P, Wilson D. Hematologic safety of dapsone gel, 5%, for topical treatment of acne vulgaris. Arch Dermatol. 2008 Dec;144(12):1564-70. doi: 10.1001/archdermatol.2008.518.