Effects of Acleara Needle Insert on Acne

Theravant

Status

Completed

Conditions

Acne Vulgaris

Treatments

Device: Acleara Acne Treatment System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01677221

Acleara-01

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

14+ years old

Volunteers

Accepts Healthy Volunteers

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.