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

May 27, 2011 updated by: Allergan

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%.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Radiant Research, Inc.
    • California
      • San Diego, California, United States, 92123
        • Therapeutics Clinical Research
      • San Francisco, California, United States, 94115
        • Department of Dermatology, University of California, San Francisco
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Dermatology Associates, PC at the Washington Hospital Center
      • Washington, District of Columbia, United States, 20060
        • Howard University Hospital Department of Dermatology
    • Florida
      • Miami, Florida, United States, 33175
        • FXM Research
      • Pembroke Pines, Florida, United States, 33024
        • University Clinical Research, Inc
    • Georgia
      • Newnan, Georgia, United States, 30263
        • MedaPhase, Inc.
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Boston Clinical Trials
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Medical Center - New Center One
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University Dermatology Clinical Trials Unit
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Skin Specialists, PC
    • New York
      • Brooklyn, New York, United States, 11203
        • Department of Dermatology SUNY Downstate Medical Center
      • New York, New York, United States, 10032
        • Columbia University Medical Center Department of Dermatology
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • Metrolina Medical Research
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Universtiy Dermatology Consultants, Inc.
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19103
        • Paddington Testing Clinic
      • Philadelphia, Pennsylvania, United States, 19107-6129
        • Society Hill Dermatology
    • South Carolina
      • Beaufort, South Carolina, United States, 29907'
        • Okatie Research Center, LLC
    • Tennessee
      • Knoxville, Tennessee, United States, 37917
        • Dermatology Associates of Knoxville
      • Nashville, Tennessee, United States, 37203
        • Dermatology Research Associates
    • Texas
      • Austin, Texas, United States, 78759
        • Dermresearch, Inc.
      • Beaumont, Texas, United States, 77701
        • DiscoveResearch, Inc.
      • Bryan, Texas, United States, 77802
        • J&S Studies, Inc.
      • Dallas, Texas, United States, 75234
        • Research Across America
      • Houston, Texas, United States, 77056
        • Suzanne Bruce and Associates, PA
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • The Education and Research Foundation, Inc.
      • Norfolk, Virginia, United States, 23507
        • Virginia Clinical Research
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Advanced Healthcare, SC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome 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.
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Investigators

  • Study Director: Steven Garrett, MS, DDS, QLT USA, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

October 21, 2005

First Submitted That Met QC Criteria

October 21, 2005

First Posted (Estimate)

October 24, 2005

Study Record Updates

Last Update Posted (Estimate)

May 30, 2011

Last Update Submitted That Met QC Criteria

May 27, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACZ ACN 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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