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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
All participants will receive treatment with the Epicare fractional nano-thulium (Tm:YAP, 1938 nm) laser device for the reduction of periorbital wrinkles.
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.
Time frame: 3 months post-Treatment #2
Physician-Reported GAIS Improvement
Physician Global Aesthetic Improvement Scale (P-GAIS): 5-point ordinal scale (1 = Worse, 2 = No Change, 3 = Improved, 4 = Much Improved, 5 = Very Much Improved).
Time frame: 3 months post-Treatment #2
Physician-Reported FWCS Improvement
Fitzpatrick Wrinkle Classification Scale (FWCS): 0-9 grading scale assessing the severity of periorbital wrinkles.Change from baseline in FWCS, assessed by the investigator.
Time frame: 3 months post-Treatment #2
Subject-Reported GAIS
Subject Global Aesthetic Improvement Scale (S-GAIS): 5-point ordinal scale reported by the participant, reflecting perceived aesthetic improvement (1 = Worse, 2 = No Change, 3 = Improved, 4 = Much Improved, 5 = Very Much Improved).
Time frame: 3 months post-Treatment #2
Subject-Reported S-GSQ
Subject Global Satisfaction Questionnaire (S-GSQ): Structured questionnaire assessing the participant's overall satisfaction with treatment results and willingness to recommend/undergo treatment again
Time frame: 3 months post-Treatment #2
Pain Assessment Using Visual Analog Scale (VAS) After Each Treatment
Visual Analog Scale (VAS) for pain: 0-10 scale (0 = no pain, 10 = worst imaginable pain).Participants rate the maximum procedural pain immediately after treatment. Recorded in the CRF for safety and tolerability evaluation.
Time frame: Immediately post-procedure at each treatment visit
Subjective Downtime Assessment After Each Treatment
Subject Downtime Questionnaire evaluating perceived post-treatment recovery and any restrictions to daily activities, typically rated on a categorical scale (e.g., None, Mild, Moderate, Severe).
Time frame: Collected at Week 1 post-treatment follow-up visits for each treatment session.
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