Effects of Acleara Needle Insert on Acne

Completed · Not applicable

Conditions studied: Acne Vulgaris

In brief

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.

Key facts

Study ID

NCT01677221

Run by

Theravant Corporation

People needed

30

Starts

2012-07-01

Expected to finish

2013-01-01

Last updated by the study team

2013-01-10

Who can join

Age: 14 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Charles County Dermatology Associates — White Plains, Maryland, United States
• Bellaire Dermatology Associates — Bellaire, Texas, United States

Full record on ClinicalTrials.gov

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