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

• Status: Completed
• Trial end date: 2017-09-11
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Derm Research, PLLC
• Treatments: Dapsone

Criteria

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.