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Evaluation of the Safety and Performance of Epicare for the Treatment of Periorbital Wrinkles
Sponsor: Laser team Ltd
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.
Official title: A Prospective, Interventional, Evaluator-Blinded, Multi-Center Study for the Assessment of the Safety and Performance of Epicare for the Treatment of Periorbital Wrinkles
Key Details
Gender
All
Age Range
25 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-03-30
Completion Date
2027-04-30
Last Updated
2025-12-02
Healthy Volunteers
Yes
Conditions
Interventions
Epicare
All participants will receive treatment with the Epicare fractional nano-thulium (Tm:YAP, 1938 nm) laser device for the reduction of periorbital wrinkles.