Effects of Acleara Needle Insert on Acne



Status:Completed
Conditions:Acne, Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:14 - Any
Updated:10/14/2017
Start Date:July 2012
End Date:January 2013

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Trial Summary
Trial Overview
Inclusion Criteria

A Clinical Trial Investigating the Effects of Acleara Needle Insert on Acne Vulgaris

This prospective, open-label study will be conducted in 15 healthy subjects per clinical site
ages 14 or older who meet the inclusion/exclusion criteria. Each subject may have up to 5
lesions treated on the face, chest or back with the Acleara insert. Subjects will receive up
to 3 follow up visits and evaluated for improvement in acne lesions and monitored for any
adverse events.


Inclusion Criteria:

- Subjects >14 years of age

- Subject has mild to moderate acne vulgaris on the face, chest or back.

- Subject has one or more inflammatory acne lesions on face, chest or back.

- Willingness to participate in the study

- Informed consent agreement signed by the subject

- Willingness to follow the treatment schedule and post treatment care requirements

- Willingness to remain on current acne therapy as directed by the Investigator.

Exclusion Criteria:

- Subject has an infection or other dermatologic condition (aside from acne) in the area
to be treated

- Subject is immunosuppressed

- Subject is unable to comply with treatment or follow-up visits

- Any other condition or laboratory value that would, in the professional opinion of the
investigator, potentially affect the subject's response or the integrity of the data
or would pose an unacceptable risk to the subject.
We found this trial at
2
sites
Charles County Dermatology Associates
White Plains, Maryland 20695
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White Plains, MD
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Bellaire Dermatology Associates
Bellaire, Texas 77401
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Bellaire, TX
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