Active — Not RecruitingEarly Phase 1

Fractional Laser vs. Ultrasound for Periorbital Wrinkles

United States20 participantsStarted 2012-02

Plain-language summary

The primary objective of this study is to compare the efficacy of intense focused ultrasound and carbon dioxide-fractionated laser for treatment of periorbital wrinkles.

Who can participate

Age range35 Years – 60 Years

SexALL

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Inclusion criteria

✓. Age 35-60 years old male and female subjects with moderate lower eyelid rhytids and crowsfeet
✓. Subjects with Fitzpatrick skin type I-III.
✓. Subjects who are willing, have the ability to understand and provide informed consent, and are able to 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 were 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 periorbital treatment with energy devices.
✕. Subjects who are allergic to lidocaine or prilocaine.
✕. Subjects who have a history of abnormal scarring in the treatment area.
✕. Subject who have ectropion or or other eyelid disfigurement.
✕. Subjects who have history of isotretinoin use in the preceding year
✕. Pregnant or lactating individuals

What they're measuring

Global Improvement Scale

Timeframe: 3 months

Quantitative eyelid laxity scale

Timeframe: 3 months

Trial details

NCT IDNCT01529983

SponsorNorthwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

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