NCT07114562

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

A Prospective, Interventional, Evaluator-Blinded, Multi-Center Study for the Assessment of the Safety and Performance of Epicare for the Treatment of Periorbital Wrinkles

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Laser team Ltd · Industry
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

The Epicare device utilizes fractional nano-thulium (Tm:YAP 1938 nm) laser technology to create precise ablative micro-columns surrounded by adjustable coagulative zones, stimulating collagen regeneration and dermal remodeling while minimizing thermal injury and downtime. This clinical investigation will enroll 50 adults with Fitzpatrick skin types I-V and bilateral, approximately symmetrical periorbital wrinkles (FWCS 4-9). Participants undergo standardized photography, FWCS scoring, GAIS evaluations, pain assessment (VAS), downtime assessments, and adverse event monitoring. Treatment #1 occurs at baseline and an optional Treatment #2 may be performed at Month 2. The End-of-Study visit occurs 3 months after the last treatment (Month 5 for two-treatment participants). The study evaluates performance outcomes (FWCS, GAIS, satisfaction) and safety (device-related adverse events). No interim analysis is planned. Data will be analyzed descriptively. This pivotal clinical investigation is intended to establish the safety and performance of the Epicare device for aesthetic treatment of periorbital wrinkles.

Conditions

• Periorbital Wrinkles

Interventions

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

Timeline

• Start date: 2026-03-30
• Primary completion: 2027-03-30
• Completion: 2027-04-30
• First posted: 2025-08-11
• Last updated: 2025-12-02