Fractional Laser vs. Ultrasound for Periorbital Wrinkles

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Wrinkles

Intervention / Treatment
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* Procedure: Laser treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fractional photothermolysis<br>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 | Procedure: Laser treatment<br>* 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<br>|
| Active Comparator: High-intensity focused ultrasound<br>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. | Procedure: Laser treatment<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Improvement Scale | Global improvement scale score, as a percent improvement from baseline to 1 and 3 months, respectively, after treatment. Two non-treating dermatologists will independently blindly evaluate the photographs at baseline, 1 and 3 months after treatment; differences will be resolved via a forced agreement process. | 3 months | 
| Quantitative eyelid laxity scale | Two non-treating dermatologists will independently blindly evaluate the photographs at baseline, 1 and 3 months after treatment; differences will be resolved via a forced agreement process. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Satisfaction | Subject satisfaction will be determined by a satisfaction questionnaire, and subjects will be asked to select the treatment side they preferred | 10 years | 
| Adverse events | Any adverse events related to the use of the fractionated laser and ultrasound-tightening device (e.g. infection, prolonged erythema, prolonged edema, bleeding, ulceration, erosion or pigmentation) will be recorded. | 10 years |