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

Study Overview
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Brief Summary
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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 Description
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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.

Official Title
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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 Scars.

Conditions
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Cicatrix

Intervention / Treatment
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* Device: Fractional Radiofrequency
* Device: 1550-nm Fractional Photothermolysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects age 18 years and older. Subjects with bilateral 2x2 cm areas of ice pick and/or boxcar acne scars on their face. Subjects are in good health. Subjects have the willingness and the ability to understand and provide informed consent and communicate with the investigator. Exclusion Criteria: Subjects who have received injectable soft-tissue augmentation materials to the face, or facial ablative resurfacing, within the past 6 months. Subjects who have received injectable botulinum toxin to the face, or any nonablative laser treatment to the face, within the past 3 months. Subjects who have local infections, open facial wounds, or other significant local skin disease that would interfere with acne scar treatment with energy devices. Subjects who are allergic to lidocaine or prilocaine. Subjects who have a history of abnormal scarring in the treatment area, such as keloid scar formation. Subjects who have ectropion or or other eyelid disfigurement. Subjects who have a history of isotretinoin use in the preceding year. Pregnant or lactating individuals.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fractional Radiofrequency<br>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. | Device: Fractional Radiofrequency<br> <br> * Other names: ePrime;|
| Active Comparator: 1550-nm Fractional Photothermolysis<br>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. | Device: 1550-nm Fractional Photothermolysis<br> <br> * Other names: Fraxel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in best overall cosmetic appearance (right side or left side better)rated by a blinded dermatologist from baseline to 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). | 1 hour at baseline and week 16 |