Efficacy and Safety of Aczone 7.5% Gel in the Treatment of Truncal Acne Vulgaris

March 20, 2019 updated by: Derm Research, PLLC
To determine if Dapsone (Aczone) 7.5% gel is a safe and effective treatment for acne on the trunk

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open label pilot study to determine the safety and efficacy of Dapsone (Aczone) 7.5% gel applied daily to the trunk for acne. Subjects will apply Dapsone for 16 weeks.

Study Type

Interventional

Enrollment (Actual)

20

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
    • California
      • Sacramento, California, United States, 95819
        • Dermatology and Laser Surgery
    • Kentucky
      • Louisville, Kentucky, United States, 40014
        • DermResearch, PLLC
    • Nevada
      • Las Vegas, Nevada, United States, 89117
        • James Q. DelRosso DO, LLC

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:

  • Male and female subjects of any race and at least 12 years of age.
  • Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline and practice a reliable method of contraception throughout the study.
  • Truncal acne IGA score of 3.
  • Able to understand the requirements of study and sign Informed Consent/HIPAA forms.

Exclusion Criteria:

  • Female subjects who are pregnant , breast feeding or are of childbearing potential who are not willing to use a reliable method birth control.
  • Subjects who have an allergy or sensitivity to any component of the test medication.
  • Subjects who have not complied with the proper wash out periods for prohibited medications.
  • Evidence of recent drug or alcohol abuse.
  • Skin disease /disorder that might interfere with the diagnosis or evaluation of truncal acne.
  • Exposure to an investigational drug within 30 days of the Baseline visit.
  • Medical condition that contraindicates the subject's participation in the study.
  • History of poor cooperation, non-compliance with medical treatment or unreliability.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dapsone gel 7.5%
Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks.
Drug: Dapsone 7.5 % gel
Dapsone gel 7.5% applied once daily to truncal acne
Other Names:
  • Aczone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Subjects Who Achieve at Least a Two Grade Improvement and a Rating of Clear or Almost Clear on the Investigator Global Assessment (IGA) Scale
Time Frame: 16 weeks
Investigator will evaluate global acne severity using the IGA scale as follows: 1= Clear Skin, 2 = Almost Clear, 3 = Mild Severity, 4 = Severe, 5 = Very Severe
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The Percent Change in Inflammatory Lesion Count at Week 16 Compared to Baseline
Time Frame: 16 Weeks
16 Weeks
The Percent Change in Non-inflammatory Lesion Count at Week 16 Compared to Baseline
Time Frame: 16 Weeks
16 Weeks
The Percent Change in Total Lesion Count at Week 16 Compared to Baseline
Time Frame: 16 Weeks
16 Weeks

Collaborators and Investigators

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

Sponsor

Derm Research, PLLC

Investigators

  • Study Director: Leon H. Kircik, M.D., DermResearch PLLC

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

October 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 11, 2017

Study Registration Dates

First Submitted

October 4, 2016

First Submitted That Met QC Criteria

October 24, 2016

First Posted (Estimate)

October 25, 2016

Study Record Updates

Last Update Posted (Actual)

April 3, 2019

Last Update Submitted That Met QC Criteria

March 20, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACZ1601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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