20 Participants Needed

Laser Resurfacing for Wrinkles

MD
LD
Overseen ByLeah Dickerson
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a laser treatment (2910 nm Erbium-Doped Fluoride Fiber Glass Laser) designed to reduce wrinkles around the mouth. It will evaluate the treatment's effectiveness, safety, and participant satisfaction. Individuals with noticeable wrinkles around the mouth, Fitzpatrick skin types I-IV, and a willingness to avoid certain skincare products during the study may be suitable candidates. Participants will undergo up to two laser sessions and return for follow-up visits to assess improvements. As an unphased trial, this study allows participants to contribute to innovative research in cosmetic dermatology.

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications like Accutane, steroids, and retinoids at least one month before joining. You also need to avoid using cosmeceutical or topical agents during the study unless directed by the investigator.

What prior data suggests that this laser treatment is safe for addressing perioral lines and wrinkles?

Research has shown that the 2910 nm Erbium-Doped Fluoride Fiber Glass Laser is generally safe for treating skin issues like wrinkles and signs of aging. In past studies, this laser proved safe for use on the whole face and neck. Participants experienced minimal risks while seeing improvements in their skin.

The laser treats both the top and deeper layers of the skin, helping to refresh and rejuvenate it. Case studies demonstrated its effectiveness with a low chance of side effects or problems, indicating that most people tolerate it well. Participants in these studies expressed satisfaction with their results, supporting its safety. Always consult a healthcare provider to understand personal risks and benefits before joining a clinical trial.12345

Why are researchers excited about this trial?

Unlike the standard wrinkle treatments like topical retinoids, chemical peels, or traditional laser resurfacing, the 2910 nm Erbium-Doped Fluoride Fiber Glass Laser offers a unique dual-action approach. It combines superficial epidermal ablation with deep dermal rejuvenation, addressing both surface wrinkles and deeper skin layers simultaneously. Researchers are excited because this laser targets perioral lines and wrinkles with precision while potentially offering less downtime and faster results compared to other laser options.

What evidence suggests that this laser treatment is effective for wrinkles?

Research has shown that the 2910 nm Erbium-Doped Fluoride Fiber Glass Laser, which participants in this trial will receive, effectively treats wrinkles and other signs of aging skin. Studies have found that this laser is safe and can enhance the appearance of advanced sun-damaged skin and wrinkles on the face and neck. The treatment typically involves the laser removing the top layer of skin and targeting deeper layers to rejuvenate the skin, resulting in visible improvements. Specifically, past patients experienced moderate improvements after three sessions. Additionally, recovery is generally quicker and less painful compared to other methods.12367

Who Is on the Research Team?

PF

Paul Friedman, MD

Principal Investigator

Director, Dermatology & Laser Surgery Center Clinical Assistant Professor of Dermatology, UT Medical School

Are You a Good Fit for This Trial?

This trial is for individuals with advanced perioral lines and wrinkles, commonly known as smile or lipstick lines. Participants should be seeking treatment for these signs of aging or photoaging. The specific eligibility criteria are not provided, so it's assumed that the study will include typical considerations such as age range, skin type, and health status.

Inclusion Criteria

Subjects must agree to refrain from using cosmeceutical agents or topical agents during the study, except as directed by study investigator
Subjects of childbearing potential have been on an acceptable form of contraception for 30 days prior to enrollment and agree to continue using throughout the course of the study
Fitzpatrick skin type I-IV
See 7 more

Exclusion Criteria

Subjects must not have a known allergy to lidocaine or epinephrine, topical or injectable products containing lidocaine or any numbing medications
Subject must not have had a pulse dye or vascular laser, non-ablative laser, microneedling, or energy-based device treatment in the treatment area within the last 3 months
Subject must not have active sunburn or excessively tanned skin
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to two treatments with the 2,910 nm mid-infrared Fiber Laser, spaced 6-8 weeks apart

6-8 weeks per treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 1 month and 3 months

3 months
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • 2910 nm Erbium-Doped Fluoride Fiber Glass Laser
Trial Overview The trial is testing a new laser resurfacing treatment using a 2910 nm Erbium-Doped Fluoride Fiber Laser (UltraClear). It aims to improve the appearance of wrinkles around the mouth by removing layers of skin and stimulating collagen production through two treatments spaced about 6-8 weeks apart.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Part 2 Clinical Study ProcedureExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

FA Corporation

Lead Sponsor

Trials
2
Recruited
5+

Citations

2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the ...The primary objective is to assess the efficacy, safety and satisfaction associated with the resurfacing treatment of perioral lines and ...
2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the ...The primary objective is to assess the efficacy, safety and satisfaction associated with the resurfacing treatment of perioral lines and ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38353284/
Full-face and neck resurfacing with a novel ablative ...Conclusions: Treatment with the novel 2910 nm fiber laser is safe and effective in treating advanced photoaging and rhytides. Three treatments produced moderate ...
Full‐face and neck resurfacing with a novel ablative ...These study results demonstrate that treatment with a new 2910 nm fiber laser is safe and effective in treating advanced photoaging and rhytides.
Publications & NewsStudy Demonstrates Faster Recovery, Less Pain After Facial Resurfacing with 2910 nm Fiber Laser. A 2910-nm erbium-doped fluoride glass fiber ...
K210847 - Sharon Timberlake - accessdata.fda.gov2,910nm. The system incorporates a fiber couple laser diode assembly pumping erbium doped fluoride glass fiber to generate laser emission.
UltraClear Laser Case StudiesThis white paper explored the efficacy and safety of the novel 2910 nm fractional ablative fiber laser in treating pigmented lesions with minimal risk.
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