Efficacy and Safety of Aczone 7.5% Gel in the Treatment of Truncal Acne Vulgaris
Status: | Completed |
---|---|
Conditions: | Acne, Acne, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 12 - Any |
Updated: | 4/5/2019 |
Start Date: | October 2016 |
End Date: | September 11, 2017 |
To determine if Dapsone (Aczone) 7.5% gel is a safe and effective treatment for acne on the
trunk
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.
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.
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