Evaluation of the Safety and Performance of Epicare for the Treatment of Periorbital Wrinkles

NCT07114562 | Not Yet Recruiting DMC

• 1 other identifier: PL-001
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, interventional, evaluator-blinded, multi-center clinical study designed to assess the safety and performance of the Epicare fractional nano-thulium (Tm:YAP 1938 nm) laser system for the treatment of moderate to severe periorbital wrinkles in adults aged 25-65. Up to 50 participants will receive one Epicare treatment at baseline, with an optional second treatment at Month 2 based on clinical assessment. The primary endpoint is the proportion of participants achieving at least a 1-grade improvement on the Fitzpatrick Wrinkle Classification Scale (FWCS) three months after the last treatment, as evaluated by at least 2 of 3 independent, blinded reviewers of standardized photographs.

Conditions

Periorbital Wrinkles

Keywords

Wrinkles; Periorbital wrinkles; Aesthetic dermatology; Laser resurfacing; Fractional thulium laser; Epicare

Outcome Measures

Primary Outcomes (1)

• Fitzpatrick Wrinkle Classification Scale (FWCS) improvement after three months from last treatment.

  Proportion of participants achieving ≥1-grade improvement on the Fitzpatrick Wrinkle Classification Scale (FWCS) three months after Treatment #2, evaluated by ≥2 of 3 independent blinded reviewers.

  3 months post-Treatment #2

Secondary Outcomes (6)

• Physician-Reported GAIS Improvement

  3 months post-Treatment #2

• Physician-Reported FWCS Improvement

  3 months post-Treatment #2

• Subject-Reported GAIS

  3 months post-Treatment #2

• Subject-Reported S-GSQ

  3 months post-Treatment #2

• Pain Assessment Using Visual Analog Scale (VAS) After Each Treatment

  Immediately post-procedure at each treatment visit

Study Arms (1)

Epicare treatment arm

EXPERIMENTAL

All participants will receive treatment with the Epicare fractional nano-thulium (Tm:YAP, 1938 nm) laser device for the reduction of periorbital wrinkles.

Device: Epicare

Interventions

Epicare DEVICE

All participants will receive treatment with the Epicare fractional nano-thulium (Tm:YAP, 1938 nm) laser device for the reduction of periorbital wrinkles.

Epicare treatment arm

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 25-65 years of age, in general good health.
• Seeking a reduction in the appearance of periorbital wrinkles.
• Bilateral and approximately symmetrical periorbital wrinkles with a Fitzpatrick Wrinkle Classification Scale (FWCS) score 4-9, as assessed by the treating investigator.
• Fitzpatrick skin type I-V.
• Able to understand the study requirements and sign an EC/IRB-approved informed consent form prior to any study procedures.
• Willing and able to comply with the treatment and follow-up schedule, pre- and post-treatment instructions, and allow standardized photography.
• Willing to withhold additional aesthetic therapies to the treatment area (e.g., fillers, resurfacing procedures) for the entire study duration.

You may not qualify if:

• Known bleeding disorder (e.g., thrombocytopenia, thrombasthenia, von Willebrand's disease).
• Immunocompromised or immunosuppressed (e.g., AIDS, HIV, or immunosuppressive therapy).
• Planned or recent use of anti-platelets, anti-coagulants, thrombolytics, ACE inhibitors, vitamin E, or anti-inflammatory drugs from 1 week prior to 1 month after treatment.
• Systemic corticosteroid or anabolic steroid use within 30 days prior to enrollment (standard inhaled/nasal corticosteroids are permitted).
• Use of weight loss medications before or during the study.
• History of chronic or recurrent infection or inflammation that would preclude participation.
• Severe allergies with history of anaphylaxis.
• History of malignancy within 5 years prior to enrollment.
• Infection, inflammation, or active dermatologic disease in the face.
• Pregnant, breastfeeding, or planning pregnancy during the study; women of childbearing potential not using reliable contraception for ≥3 months prior and throughout the study.
• Exposure to an investigational drug or device within 3 months prior to enrollment or during the study.
• Prior permanent facial injections (e.g., silicone, grafting) or any upper-face surgery.
• Neurotoxin treatments in the upper face within 6 months prior to enrollment.
• Semi-permanent filler (e.g., collagen, CaHA) or any dermal filler (e.g., hyaluronic acid) in the upper face within 18 months prior to enrollment.
• Any active or passive implant in the treatment area (metallic, silicone, electronic, or injected chemical substance).

Sponsors & Collaborators

• Laser team Ltd: lead

Study Officials

• Yoav Gronovich, Dr.

  Shaare Zedek Medical Center

  PRINCIPAL INVESTIGATOR

• Avshalom Shalom, Prof.

  Meir Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pini Ben Elazar

CONTACT

+972-52-3447333; pinib@lasertm.com

Sapir Brosh

CONTACT

+972-54-6331423; sapirb@lasertm.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Evaluator-Blinded (photograph reviewers; subjects and investigators unblinded)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Allocation: Non-Randomized Intervention Model: Single Group Assignment (all participants receive Epicare treatment) Masking: Evaluator-Blinded (photographs assessed by blinded independent reviewers) Primary Purpose: Treatment

Study Record Dates

• First Submitted: August 3, 2025
• First Posted: August 11, 2025
• Study Start: March 30, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share