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

Sponsor:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00243542

Purpose

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.

Condition	Intervention	Phase
Acne Vulgaris	Drug: ACZONE Gel, 5% Drug: Vehicle	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
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%.

Resource links provided by NLM:

Genetics Home Reference related topics: glucose-6-phosphate dehydrogenase deficiency

MedlinePlus related topics: Acne

Drug Information available for: Dapsone

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

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.
The safety evaluable data set will be used, and each variable will be summarized using descriptive statistics.
Analyses of clinical lab values, AEs, vitals, and concomitant meds will be performed on all subjects who received treatment.

Secondary Outcome Measures:

Acne Lesions: Tabular summaries of total lesion counts will be provided by appropriate descriptive statistics.

Enrollment:	64
Study Start Date:	November 2005
Study Completion Date:	October 2006
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Male or female ≥12 years of age.
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.
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:

A dermal examination reveals the presence of severe cystic acne or acne conglobata.
Treatment with isotretinoin (Accutane®) within 3 months of baseline and throughout the study.
Subjects predisposed to anemia for other medical reasons, including but not limited to gastrointestinal bleeding and cancer.
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.
Subjects who are using medication or eating foods that could potentially cause a hemolytic event in individuals with G6PD deficiency during the study.
Facial surgery (dermabrasion, laser resurfacing or other facial cosmetic surgeries) within 3 months of baseline and throughout the study.
A history of hypersensitivity to dapsone, parabens, or any component of the study products.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00243542

Show 29 Study Locations

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Steven Garrett, MS, DDS

QLT USA, Inc.

More Information

No publications provided by Allergan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00243542 History of Changes
Other Study ID Numbers:	ACZ ACN 01
Study First Received:	October 21, 2005
Last Updated:	May 27, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Allergan:

Acne, G6PD deficiency, Dapsone

Additional relevant MeSH terms:

Acne Vulgaris
Glucosephosphate Dehydrogenase Deficiency
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Genetic Diseases, Inborn
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors

Metabolic Diseases
Dapsone
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on February 07, 2012