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

Acne Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02944461
• Other study ID #: ACZ1601
• Status: Completed
• Phase: Phase 4
• Start date: October 2016
• Est. completion date: September 11, 2017

Study information

• Verified date: March 2019
• Source: Derm Research, PLLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 11, 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

Intervention

Drug:
• Dapsone 7.5 % gel
Dapsone gel 7.5% applied once daily to truncal acne

Locations

Country	Name	City	State
United States	James Q. DelRosso DO, LLC	Las Vegas	Nevada
United States	DermResearch, PLLC	Louisville	Kentucky
United States	Dermatology and Laser Surgery	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Derm Research, PLLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	The Percent Change in Inflammatory Lesion Count at Week 16 Compared to Baseline		16 Weeks
Secondary	The Percent Change in Non-inflammatory Lesion Count at Week 16 Compared to Baseline		16 Weeks
Secondary	The Percent Change in Total Lesion Count at Week 16 Compared to Baseline		16 Weeks