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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02944461
Other study ID # ACZ1601
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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