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 range

35 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Wrinkles trials