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

Phase 4

Completed

• Conditions: Acne
• Interventions: Drug: Dapsone 7.5 % gel

• Registration Number: NCT02944461
• Lead Sponsor: Derm Research, PLLC

Brief Summary

To determine if Dapsone (Aczone) 7.5% gel is a safe and effective treatment for acne on the trunk

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 Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-04
• Study First Submitted QC: 2016-10-24
• Study First Posted: 2016-10-25
• Primary Completion: 2017-09
• Study Completion: 2017-09-11
• Results First Submitted: 2019-02-07
• Results First Submitted QC: 2019-02-07
• Status Verified: 2019-03
• Results First Posted: 2019-03-01
• Last Update Submitted: 2019-03-20
• Last Update Posted: 2019-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dapsone gel 7.5%	Dapsone 7.5 % gel	Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks.

Primary Outcome Measures

Name	Time	Method
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	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

Secondary Outcome Measures

Name	Time	Method
The Percent Change in Inflammatory Lesion Count at Week 16 Compared to Baseline	16 Weeks
The Percent Change in Non-inflammatory Lesion Count at Week 16 Compared to Baseline	16 Weeks
The Percent Change in Total Lesion Count at Week 16 Compared to Baseline	16 Weeks

Trial Locations

Locations (3)

Dermatology and Laser Surgery; 🇺🇸 Sacramento, California, United States

James Q. DelRosso DO, LLC; 🇺🇸 Las Vegas, Nevada, United States

DermResearch, PLLC; 🇺🇸 Louisville, Kentucky, United States