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

Completed · Phase 4

Conditions studied: Acne

In brief

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

Key facts

Study ID

NCT02944461

Run by

Derm Research, PLLC

People needed

20

Starts

2016-10-01

Expected to finish

2017-09-11

Last updated by the study team

2019-04-03

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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