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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-09-11

Brief Summary

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

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Detailed Description

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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.

Conditions

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Acne

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dapsone gel 7.5%

Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks.

Group Type EXPERIMENTAL

Dapsone 7.5 % gel

Intervention Type DRUG

Dapsone gel 7.5% applied once daily to truncal acne

Interventions

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Dapsone 7.5 % gel

Dapsone gel 7.5% applied once daily to truncal acne

Intervention Type DRUG

Other Intervention Names

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Aczone

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes