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

Northwestern University

Status and phase: Active, not recruiting; Phase 2

Conditions: Cicatrix

Treatments: Device: 1550-nm Fractional Photothermolysis; Device: Fractional Radiofrequency

Study type: Interventional

Funder types: Other

Identifiers

NCT01976260

STU84041

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Subjects age 18 years and older.
2. Subjects with bilateral 2x2 cm areas of ice pick and/or boxcar acne scars on their face.
3. Subjects are in good health.
4. Subjects have the willingness and the ability to understand and provide informed consent and communicate with the investigator.

Exclusion criteria

1. Subjects who have received injectable soft-tissue augmentation materials to the face, or facial ablative resurfacing, within the past 6 months.
2. Subjects who have received injectable botulinum toxin to the face, or any nonablative laser treatment to the face, within the past 3 months.
3. Subjects who have local infections, open facial wounds, or other significant local skin disease that would interfere with acne scar treatment with energy devices.
4. Subjects who are allergic to lidocaine or prilocaine.
5. Subjects who have a history of abnormal scarring in the treatment area, such as keloid scar formation.
6. Subjects who have ectropion or or other eyelid disfigurement.
7. Subjects who have a history of isotretinoin use in the preceding year.
8. Pregnant or lactating individuals.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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16 participants in 2 patient groups

Fractional Radiofrequency

Active Comparator group

Description:

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.

Treatment:

Device: Fractional Radiofrequency

1550-nm Fractional Photothermolysis

Active Comparator group

Description:

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.

Treatment:

Device: 1550-nm Fractional Photothermolysis