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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of laser treatment for wrinkles?

Research shows that laser treatment can improve the appearance of wrinkles by stimulating the production of new collagen, which is a protein that helps keep skin firm and smooth. This effect is achieved by the laser light targeting blood vessels in the skin, leading to tissue repair and rejuvenation. ^{1 2 3 4 5}

Is laser treatment for wrinkles safe?

Laser treatments for wrinkles are generally safe, with most side effects being mild and temporary, like redness and swelling. Rarely, more serious issues like scarring or infections can occur, but these can often be managed with proper care. ^{6 7 8 9 10}

How does laser treatment for wrinkles differ from other treatments?

Laser treatment for wrinkles is unique because it uses ultrashort light beams to remove superficial skin layers with minimal side effects, unlike traditional methods like surgery or chemical peels. This approach can also be combined with other treatments, such as platelet-rich plasma, to enhance collagen production and skin rejuvenation. ^{10 11 12 13 14}

Research Team

Murad Alam, MD

Principal Investigator

Northwestern University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A systematic review of outcome reporting in laser treatments for dermatological diseases. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Dermal collagen production following irradiation by dye laser and broadband light source. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Nonablative 4-MHz dual radiofrequency wand rejuvenation treatment for periorbital rhytides and midface laxity. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Laser Resurfacing and Facial Plastic Surgery Using Age, Glogau, and Fitzpatrick Rating. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Noninvasive skin measurements after CO(2) and erbium laser resurfacing. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Complications of lasers and light treatments. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Infections complicating pulsed carbon dioxide laser resurfacing for photoaged facial skin. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Complications of aesthetic laser surgery. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Ultrasound tightening of facial and neck skin: a rater-blinded prospective cohort study. [2022]

10. England pubmed.ncbi.nlm.nih.gov

A Fractional Bipolar Radiofrequency Device Combined with a Bipolar Radiofrequency and Infrared Light Treatment for Improvement in Facial Wrinkles and Overall Skin Tone and Texture. [2019]

11. Germany pubmed.ncbi.nlm.nih.gov

[Facial wrinkles--ultrapulsed CO2 laser: alternative or supplement to surgical face lift?]. [2007]

12. England pubmed.ncbi.nlm.nih.gov

Fractional carbon dioxide laser versus combined fractional CO2 laser and platelet rich plasma in treatment of facial wrinkles: A comparative split face study. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

A New 675 nm Laser Device in the Treatment of Facial Aging: A Prospective Observational Study. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

A pilot study on the treatment of facial rhytids using nonablative 585-nm pulsed dye and 532-nm Nd:YAG lasers. [2019]