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Fractional Laser

Laser treatment for Wrinkles

N/A
Waitlist Available
Led By Murad Alam, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 35-60 years old male and female subjects with moderate lower eyelid rhytids and crowsfeet
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights

Study Summary

This trial will compare the wrinkle-reducing effects of two common treatments: intense focused ultrasound and carbon dioxide-fractionated laser.

Who is the study for?
This trial is for men and women aged 35-60 with moderate wrinkles around the eyes, who have skin types I-III according to the Fitzpatrick scale. Participants must understand and consent to the study's procedures. Excluded are pregnant or breastfeeding individuals, those with certain medication histories, allergies to local anesthetics, recent facial treatments, abnormal scarring tendencies, eyelid disfigurements or significant skin diseases.Check my eligibility
What is being tested?
The study aims to compare two methods of reducing eye wrinkles: intense focused ultrasound and carbon dioxide-fractionated laser treatment. The effectiveness of these treatments in smoothing periorbital wrinkles will be evaluated against each other.See study design
What are the potential side effects?
Potential side effects may include redness, swelling at the treatment site, discomfort during application, temporary pigment changes especially in darker skin tones (hyperpigmentation), a risk of burns from laser heat and possible bruising from ultrasound waves.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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We are looking for men and women between the ages of 35 and 60 who have wrinkles around their lower eyelids and outer corners of their eyes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Global Improvement Scale
Quantitative eyelid laxity scale
Secondary outcome measures
Adverse events
Subject Satisfaction

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Fractional photothermolysisExperimental Treatment1 Intervention
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
Group II: High-intensity focused ultrasoundActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Laser treatment
2022
Completed Phase 3
~580

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,211 Total Patients Enrolled
2 Trials studying Wrinkles
24 Patients Enrolled for Wrinkles
Murad Alam, MDPrincipal InvestigatorNorthwestern University
69 Previous Clinical Trials
2,560 Total Patients Enrolled
2 Trials studying Wrinkles
24 Patients Enrolled for Wrinkles

Media Library

Laser treatment (Fractional Laser) Clinical Trial Eligibility Overview. Trial Name: NCT01529983 — N/A
Wrinkles Research Study Groups: Fractional photothermolysis, High-intensity focused ultrasound
Wrinkles Clinical Trial 2023: Laser treatment Highlights & Side Effects. Trial Name: NCT01529983 — N/A
Laser treatment (Fractional Laser) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01529983 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Texas
Indiana
Illinois
How old are they?
18 - 65
What site did they apply to?
Northwestern University Feinberg School of Medicine, Department of Dermatology
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Fractional Laser vs. Ultrasound for Periorbital Wrinkles
Murad Alam 2012. "Fractional Laser vs. Ultrasound for Periorbital Wrinkles". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01529983.
~1 spots leftby Dec 2024
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