Laser treatment for Wrinkles

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Northwestern University

Must not be taking: Isotretinoin

Disqualifiers: Local infections, Abnormal scarring, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12-16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which treatment better reduces wrinkles around the eyes: a special type of laser or focused ultrasound. The laser option uses tiny beams to improve skin texture and reduce signs of aging, while the ultrasound option employs sound waves to tighten the skin without surgery. Suitable candidates for this trial are individuals aged 35 to 60 with noticeable wrinkles around their eyes and lighter skin tones (Fitzpatrick skin type I-III). As an Early Phase 1 trial, this research focuses on understanding how these treatments work in people, offering participants the opportunity to be among the first to experience these innovative options.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, it does exclude those who have used certain facial treatments recently, so it's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that fractional photothermolysis, a type of laser treatment, is generally well-tolerated. Studies indicate that this treatment causes only minor and short-lived side effects, such as skin redness or swelling, which resolve quickly. It is considered safe, particularly for treating sun-damaged skin and wrinkles.

High-intensity focused ultrasound treatment also has FDA approval for tightening skin around the eyes. Research shows it works by heating the skin, which can help tighten it. The side effects resemble those of other skin treatments, like temporary redness or swelling.

Overall, both treatments are generally safe with few long-lasting side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Fractional photothermolysis is unique because it uses a 1550-nm laser to safely and non-surgically improve facial wrinkles, photodamage, and scarring. This method stands out from standard treatments like topical retinoids or invasive procedures because it offers precision by targeting damaged skin areas without affecting surrounding tissue. High-intensity focused ultrasound, meanwhile, uses ultrasound waves to tighten tissues without surgery, making it a compelling alternative to more invasive options like facelifts. Researchers are excited about these treatments because they provide effective, non-invasive ways to address skin aging with minimal downtime, offering new hope for those seeking to rejuvenate their appearance.

What evidence suggests that this trial's treatments could be effective for wrinkles?

In this trial, participants will receive either fractional photothermolysis or high-intensity focused ultrasound as separate treatment options. In a previous study, dermatologists observed a 60% to 70% improvement in wrinkles around the eyes after using fractional photothermolysis, with this improvement lasting over time. Research has shown that this laser method can safely reduce wrinkles and skin damage by boosting collagen, which helps tighten the skin. High-intensity focused ultrasound, another treatment in this trial, uses sound waves to heat and tighten the skin, working similarly to some laser treatments. Both methods have received FDA approval for similar skin treatments and show promise in effectively reducing wrinkles. ^{1 5 6 7 8}

Who Is on the Research Team?

Murad Alam, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

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.

Exclusion Criteria

You are currently pregnant or breastfeeding.

Subjects who have history of isotretinoin use in the preceding year

You are allergic to lidocaine or prilocaine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 1550nm-fractionated laser treatment or micro-focused ultrasound treatment on periorbital wrinkles every 6-8 weeks for a total of 2 treatments

12-16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of adverse events and subject satisfaction

3 months

Long-term Follow-up

Participants are monitored for adverse events and subject satisfaction over a long-term period

10 years

What Are the Treatments Tested in This Trial?

Interventions

• Laser treatment

Trial Overview 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.

How Is the Trial Designed?

Group I: Fractional photothermolysis Experimental Treatment 2 Interventions

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 ultrasound Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

A systematic review of 150 studies on laser treatments for skin disorders revealed significant variability in how outcomes are reported, highlighting the need for standardized outcome measures to improve the comparison and interpretation of results.

The review identified 105 different outcomes categorized into eight domains, but found a lack of focus on life impact areas such as patient satisfaction (23%), quality of life (3%), and psychological functioning (1%), indicating important aspects of treatment effectiveness are often overlooked.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of outcome reporting in laser treatments for dermatological diseases. Fransen, F., Tio, DCKS., Prinsen, CAC., et al.[2020]

Aesthetic laser surgery carries risks, and it is crucial for surgeons to understand potential adverse effects to minimize complications during procedures.

Patients should receive thorough education about the risks and expectations of laser surgery to ensure they can recognize and address any complications that may arise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of aesthetic laser surgery. Aghassi, D., Carpo, B., Eng, K., et al.[2019]

Cutaneous lasers and energy modalities like radiofrequency and ultrasound are generally safe, with rapid healing times and mild, self-resolving side effects such as redness and swelling lasting only hours to days.

While most adverse events are mild, there are some medium- to long-term risks, including changes in skin pigmentation and scarring, but these are rare and can often be managed effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of lasers and light treatments. Alam, M., Warycha, M.[2022]

Citations

1. jaad.org jaad.org/article/S0190-9622(24)00051-3/fulltext

A comparison of 1550-nm fractional photothermolysis ... Percent improvement scores found that dermatologists rated 60% to 70% improvement in periorbital wrinkles that stayed constant at both follow-up ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7118506/

Assessment of Laser Effects on Skin Rejuvenation - PMC Lasers resurfacing of skin as peeling could remove fine wrinkles of skin although, however potentially have the advantages to treat deep wrinkles by collagen ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11335465/

A faster CO2 fractional scanner system mode for skin ... The purpose of this study was to assess if a fractional CO 2 scanner modality (called moveo) results in a faster full‐face rejuvenation treatment.

4. jkslms.or.kr jkslms.or.kr/journal/view.html?uid=30&vmd=Full

Clinical Benefit of Combination Treatment with 1,550 nm ... Fractional laser using a new wavelength of 1,927 nm is expected to work on superficial skin conditions, while a 1,550 nm fractional laser was proven to be ...

5. jddonline.com jddonline.com/articles/safety-and-efficacy-of-a-1550nm1927nm-dual-wavelength-laser-for-the-treatment-of-photodamaged-skin-S1545961618P0041X/

Safety and Efficacy of a 1550nm/1927nm Dual Wavelength ... Greatest reduction in severity of other benefit areas was at the 3-month follow-up visit, with a 21% and 30% decrease in severity in fine wrinkling and tactile ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29320586/

Safety and Efficacy of a 1550nm/1927nm Dual Wavelength ... BACKGROUND: Fractional photothermolysis (FP) is a popular treatment option for photodamaged skin and addresses shortcomings of ablative skin ...

7. researchgate.net researchgate.net/publication/51862192_Side_effects_and_complications_of_fractional_1550-nm_erbium_fiber_laser_treatment_among_Asians

(PDF) Side effects and complications of fractional 1550-nm ... Fractional erbium laser treatment in Asian skin is quite safe, and the side effects in this study were relatively low. Herpes prophylaxis may not be required.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0190962224028093

Controlling treatment depth and pattern of skin injury by a ... Fractional photothermolysis is limited due to potential risks in the skin of color, while focal point technology provides a new avenue of treating with a ...