Fractional Laser Vs. Ultrasound for Periorbital Wrinkles

Northwestern University

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Wrinkles

Treatments: Procedure: Laser treatment; Device: High-intensity focused ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT01529983

STU55341

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 35 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Fractional photothermolysis

Experimental group

Description:

Fractional photothermolysis (FP) for treatment of photo- damaged skin is an FDA-approved method for treating facial rhytids. Fractionated treatment with 1550-nm laser is a safe, nonsurgical method for improvement of periorbital rhytides, photodamage, and scarring

Treatment:

Device: High-intensity focused ultrasound

Procedure: Laser treatment

High-intensity focused ultrasound

Active Comparator group

Description:

High-intensity focused ultrasound (HIFUS) is an FDA-approved method for periorbital treatment and nonablative tissue tightening. Ultrasound waves induce a vibration in the tissue, generating heat and increasing the tissue temperature within a focal area. The tissue changes depend on amount of heat and exposure duration. These findings are similar to the thermally induced changes within the skin after CO2 laser fractional ablative treatments.

Treatment:

Device: High-intensity focused ultrasound

Procedure: Laser treatment