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

NCT02944461 | Completed Phase 4 Results

• 1 other identifier: ACZ1601
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Acne

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

Dapsone gel 7.5%

EXPERIMENTAL

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

Drug: Dapsone 7.5 % gel

Interventions

Dapsone 7.5 % gel DRUG

Dapsone gel 7.5% applied once daily to truncal acne

Also known as: Aczone

Dapsone gel 7.5%

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Derm Research, PLLC: lead

Study Sites (3)

Dermatology and Laser Surgery

Sacramento, California, 95819, United States

Location

DermResearch, PLLC

Louisville, Kentucky, 40014, United States

Location

James Q. DelRosso DO, LLC

Las Vegas, Nevada, 89117, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Dapsone; Gels

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: M. McAllister
• Organization: Skin Sciences, PLLC

mmdermresearch@yahoo.com

5024519000

Study Officials

• Leon H. Kircik, M.D.

  DermResearch PLLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: October 25, 2016
• Study Start: October 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 11, 2017
• Last Updated: April 3, 2019
• Results First Posted: March 1, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)