Fractional Laser vs. Ultrasound for Periorbital Wrinkles

Wrinkles Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01529983
• Other study ID #: STU55341
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 2012
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Wrinkles

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine, Department of Dermatology	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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