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

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

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2025-12-31

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.

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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.

Conditions

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Cicatrix

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Fractional Radiofrequency

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.

Group Type ACTIVE_COMPARATOR

Fractional Radiofrequency

Intervention Type DEVICE

1550-nm Fractional Photothermolysis

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.

Group Type ACTIVE_COMPARATOR

1550-nm Fractional Photothermolysis

Intervention Type DEVICE

Interventions

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Fractional Radiofrequency

Intervention Type DEVICE

1550-nm Fractional Photothermolysis

Intervention Type DEVICE

Other Intervention Names

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ePrime Fraxel

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes