Clinical Trial: A Pilot Study Testing Fractional Radiofrequency Versus Fractional Photothermolysis for the Treatment of Acne Scars

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Pilot, Split-Face Randomized, Evaluator Blinded Study on the Effectiveness of a Bipolar Fractional Radiofrequency System Versus 1550-nm Fractional Photothermolysis for the Treatment of Acne

Brief Summary: The purpose of this study is to compare the effectiveness of the ePrime fractional radiofrequency system to the 1550-nm fractional photothermolysis system (Fraxel) in the ability to improve acne scar appearance.

Detailed Summary: Participants in this study will be patients at the dermatology clinic with icepick and boxcar acne scars on at least one 2 x 2 cm area on each side of face. Subjects will be randomly assigned to receive fractional radiofrequency treatment to either the right or left side of the face and the contralateral side will receive 1550-nm fractional photothermolysis. Subjects will receive treatments at baseline, week 4, and week 8 for a total of three treatments. Follow up visits will take place at week 16, two months following the last treatment visit. This study is a pilot study designed to determine feasibility of these procedures.
Sponsor: Northwestern University

Current Primary Outcome: Change in best overall cosmetic appearance (right side or left side better)rated by a blinded dermatologist from baseline to week 16 [ Time Frame: 1 hour at baseline and week 16 ]

The primary outcome was a blinded rating of the treatment area (Fractional Radiofrequency Versus Fractional Photothermolysis) with the best cosmetic appearance. A dermatologist will blindly evaluate the treated areas of each side from live subjects at baseline and on the final follow up visit (week 16).


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Northwestern University

Dates:
Date Received: October 15, 2013
Date Started: October 2013
Date Completion: December 2017
Last Updated: December 5, 2016
Last Verified: December 2016