Effects of Acleara Needle Insert on Acne

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acne Vulgaris

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Acleara Acne Treatment System

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes