Fractional Laser vs. Ultrasound for Periorbital Wrinkles

NCT01529983 | Active Not Recruiting Early Phase 1 FDA Device

• 1 other identifier: STU55341
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wrinkles

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Subject Satisfaction

  10 years

• Adverse events

  10 years

Study Arms (2)

Fractional photothermolysis

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

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

High-intensity focused ultrasound

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.

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

Interventions

Laser treatment PROCEDURE

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

Fractional photothermolysis; High-intensity focused ultrasound

High-intensity focused ultrasound DEVICE

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.

Fractional photothermolysis; High-intensity focused ultrasound

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Laser Therapy

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation

Study Record Dates

• First Submitted: February 7, 2012
• First Posted: February 9, 2012
• Study Start: February 1, 2012
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

US (1)