Overview

This trial is active, not recruiting.

Condition wrinkles
Treatment laser treatment
Sponsor Northwestern University
Start date February 2012
End date December 2016
Trial size 20 participants
Trial identifier NCT01529983, STU55341

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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
laser treatment
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
(Active Comparator)
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.
laser treatment
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

Primary Outcomes

Measure
Global Improvement Scale
time frame: 3 months
Quantitative eyelid laxity scale
time frame: 3 months

Secondary Outcomes

Measure
Subject Satisfaction
time frame: 10 years
Adverse events
time frame: 10 years

Eligibility Criteria

Male or female participants from 35 years up to 60 years old.

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

Additional Information

Official title A Comparison of 1550-nm Fractional Photothermolysis Versus Intense Focused Ultrasound for Treatment of Periorbital Wrinkles: A Pilot, Prospective Randomized Control Trial
Principal investigator Murad Alam, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Northwestern University.