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

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

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

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.

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.