Fractional Laser vs. Ultrasound for Periorbital Wrinkles - Full Text View

Purpose

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.

Condition	Intervention
Wrinkles	Procedure: Laser treatment

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Comparison of 1550-nm Fractional Photothermolysis Versus Intense Focused Ultrasound for Treatment of Periorbital Wrinkles: A Pilot, Prospective Randomized Control Trial

Further study details as provided by Northwestern University:

Primary Outcome Measures:

Global Improvement Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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.
Quantitative eyelid laxity scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Subject Satisfaction [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Subject satisfaction will be determined by a satisfaction questionnaire, and subjects will be asked to select the treatment side they preferred
Adverse events [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
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.

Estimated Enrollment:	20
Study Start Date:	February 2012
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Fractional photothermolysis 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 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 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 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

Arms

Assigned Interventions

Experimental: Fractional photothermolysis

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

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

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

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

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

Ages Eligible for Study:	35 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01529983

Locations

United States, Illinois
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

Investigators

Principal Investigator:

Murad Alam, MD

Northwestern University

More Information

No publications provided

Responsible Party:	Murad Alam, Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation, Northwestern University
ClinicalTrials.gov Identifier:	NCT01529983 History of Changes
Other Study ID Numbers:	STU55341
Study First Received:	February 7, 2012
Last Updated:	March 26, 2013
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on June 18, 2013