Evaluation of a Photopneumatic System for the Treatment of Acne
The purpose of the study is to evaluate the safety and efficacy of a photopneumatic therapy for the treatment of acne and concomitant symptoms associated with the disease, including erythema.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Study Start Date:||December 2010|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Device: Photopneumatic therapy
Use of intense pulsed light (photo) in combination with vacuum technology (pneumatic) to treat mild to moderate acne.
The primary aims of the study will be to demonstrate the safety and efficacy of using a photopneumatic system for treatment of mild to moderate acne on the face or body - including neck, chest, and back - of up to 24 subjects. To support this clinical assessment, the affected areas to be treated will be documented at baseline, at each subsequent treatment visit (up to 6 treatments), and at one (1) month and three (3) months following final treatment.