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Fractional Laser vs. Ultrasound for Periorbital Wrinkles | Clinical Trials | Clareo Health

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Fractional Laser vs. Ultrasound for Periorbital Wrinkles

A Comparison of 1550-nm Fractional Photothermolysis Versus Intense Focused Ultrasound for Treatment of Periorbital Wrinkles: A Pilot, Prospective Randomized Control Trial

NCT01529983•Northwestern University

View on ClinicalTrials.gov

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.

Detailed Description

This is a prospective randomized comparison study comparing the efficacy of micro-focused ultrasound versus fractionated carbon dioxide laser for treatment of periorbital wrinkles. Subjects who meet inclusion and exclusion criteria will be enrolled in the study. The treated sites are both lower eyelids and lateral orbits. Each side will be randomized to receive 1550nm-fractionated laser treatment on one side and the contralateral side will receive micro-focused ultrasound treatment every 6-8 weeks for a total of 2 treatments.

Eligibility

Age

35 - 60 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Age 35-60 years old male and female subjects with moderate lower eyelid rhytids and crowsfeet
•2. Subjects with Fitzpatrick skin type I-III.
•3. Subjects who are willing, have the ability to understand and provide informed consent, and are able to 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 were 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 periorbital 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.
•6. Subject who have ectropion or or other eyelid disfigurement.
•7. Subjects who have history of isotretinoin use in the preceding year
•8. Pregnant or lactating individuals

Locations (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, United States

Key Dates

Start Date

February 1, 2012

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

January 31, 2025

Enrollment

ESTIMATED participants

Conditions

Wrinkles

Interventions

Laser treatment

PROCEDURE

High-intensity focused ultrasound

DEVICE

Evaluation of Facial HA Dermal Fillers in Real-Life Conditions

NCT07255261

Lips EnhancementPerioral Wrinkles+3 more

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RECRUITINGNA

2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the Treatment of Advanced Perioral Lines and Wrinkles

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Photodamaged SkinRhytids+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 31, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Fractional Laser vs. Ultrasound for Periorbital Wrinkles

Inclusion Criteria

Exclusion Criteria

Evaluation of Facial HA Dermal Fillers in Real-Life Conditions

2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the Treatment of Advanced Perioral Lines and Wrinkles

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Randomized Masked Trial of Injectable Cross-Linked Hyaluronic Acid for Moderate-to-Severe Nasolabial Folds

A Study Assessing KB304 for the Treatment of Wrinkles in Women

BC-101 in Treatment of Nasolabial Fold Wrinkles