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

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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.
We found this trial at
3
sites
Sacramento, California 95819
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Sacramento, CA
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Las Vegas, Nevada 89117
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Las Vegas, NV
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Louisville, Kentucky 40217
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Louisville, KY
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