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

Derm Research

Status and phase

Completed

Phase 4

Conditions

Acne

Treatments

Drug: Dapsone 7.5 % gel

Study type

Interventional

Funder types

Other

Identifiers

NCT02944461

ACZ1601

Details and patient eligibility

About

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

Full 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.

Enrollment

20 patients

Sex

All

Ages

12+ years old

Volunteers

Accepts Healthy Volunteers

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.