Evaluation of the Safety and Performance of Epicare for the Treatment of Periorbital Wrinkles
- Conditions
- Wrinkle
- Registration Number
- NCT07114562
- Lead Sponsor
- Laser team Ltd
- Brief Summary
This is a prospective, interventional, evaluator-blinded, multi-center study designed to assess the safety and performance of the Epicare device for the treatment of moderate to severe periorbital wrinkles in adults aged 25 to 65 years.
Up to 50 participants will receive a single Epicare laser treatment, with an optional second treatment at Month 2 if clinically indicated. Follow-up visits will occur at Week 1, Month 2, and at 3 or 5 months post-treatment (End of Study), depending on whether one or two treatments are administered.
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 assessed by at least 2 of 3 blinded, independent reviewers using standardized photography.
Secondary endpoints include physician and subject global aesthetic improvement (GAIS), subject satisfaction (S-GSQ), pain assessment (VAS), and downtime evaluation. Safety will be assessed through the incidence of device-related adverse events.
- Detailed Description
This study is a prospective, interventional, evaluator-blinded, multi-center clinical investigation designed to assess the safety and performance of the Epicare device for the treatment of moderate to severe periorbital wrinkles in adult participants. Epicare is a non-invasive, fractional nano-thulium (Tm:YAP, 1938 nm) laser system that delivers controlled ablative and coagulative microcolumns to stimulate dermal remodeling, collagen production, and wrinkle reduction, while minimizing thermal damage and downtime.
Up to 50 participants, aged 25 to 65 years, with Fitzpatrick skin types I-V and bilateral, approximately symmetrical periorbital wrinkles (FWCS score 4-9) will be enrolled at two clinical sites in Israel. Each participant will receive one Epicare treatment (Treatment #1) at baseline. A second, optional treatment (Treatment #2) may be administered at Month 2 based on the investigator's clinical evaluation. Participants will be followed for 3 months after the last treatment, resulting in an individual study duration of approximately 3-5 months.
The visit schedule includes:
Screening (≤30 days prior to treatment) - eligibility confirmation, medical history, baseline photography.
Baseline/Treatment #1 (Day 1) - first Epicare session, VAS pain assessment, post-treatment instructions.
Safety Phone Call (Day 2 post-treatment) - early AE assessment.
Week 1 Follow-Up - dermatologic evaluation, photography, AE documentation, downtime questionnaire.
Month 2 Assessment (±7 days) - clinical evaluation, photography, FWCS and GAIS scoring, S-GSQ, and optional Treatment #2.
Safety Phone Call (Day 2 post-Treatment #2) - if a second treatment is performed.
End of Study (Month 3 for one treatment / Month 5 for two treatments) - final assessments, FWCS, GAIS, S-GAIS, S-GSQ, and AE review.
The primary performance endpoint is the proportion of participants demonstrating ≥1-grade improvement on the Fitzpatrick Wrinkle Classification Scale (FWCS) three months after the last treatment, as confirmed by at least 2 of 3 independent, blinded reviewers evaluating standardized photographs.
Secondary endpoints include:
Physician-reported GAIS and FWCS improvement.
Subject-reported GAIS and S-GSQ.
Pain assessment using VAS after each treatment.
Subjective downtime assessment after each treatment.
Safety endpoints include the incidence, severity, and relationship of device-related adverse events (AEs) throughout the study.
The sample size of 50 participants is based on an expected 65% responder rate for the primary endpoint. Data will be analyzed descriptively using SAS® 9.4 or higher, with no interim analysis or data imputation planned.
This study aims to generate pivotal clinical data to support the safety, performance, and potential market clearance of the Epicare device for aesthetic treatment of periorbital wrinkles.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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.
- 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).
- Initiation of over-the-counter anti-wrinkle products (e.g., alpha-hydroxy acids) or prescription treatments (e.g., Retin-A, micro-dermabrasion, chemical peels) within 4 weeks prior to enrollment or planned use during the study.
- Occupations involving continuous or routine sun exposure (e.g., lifeguards, outdoor workers).
- History of smoking within the past 5 years.
- Planned bariatric surgery or recent drastic weight loss.
- Unstable body weight during the study.
- Any other medical condition, laboratory abnormality, or investigator judgment that could affect compliance, safety, or data integrity.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Fitzpatrick Wrinkle Classification Scale (FWCS) improvement after three months from last treatment. 3 months post treatment The primary performance endpoint is the proportion of participants demonstrating ≥1-grade improvement on the Fitzpatrick Wrinkle Classification Scale (FWCS) three months after the last treatment, as confirmed by at least 2 of 3 independent, blinded reviewers evaluating standardized photographs.
- Secondary Outcome Measures
Name Time Method Physician-Reported GAIS Improvement 3 months after the last Epicare treatment 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).
Physician-Reported FWCS Improvement 3 months after the last Epicare treatment Fitzpatrick Wrinkle Classification Scale (FWCS): 0-9 grading scale assessing the severity of periorbital wrinkles.
Subject-Reported GAIS 3 months after the last Epicare treatment 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).
Subject-Reported S-GSQ 3 months after the last Epicare treatment Subject Global Satisfaction Questionnaire (S-GSQ): Structured questionnaire assessing the participant's overall satisfaction with treatment results and willingness to recommend/undergo treatment again
Pain Assessment Using Visual Analog Scale (VAS) After Each Treatment Immediately post-procedure at each treatment visit 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.Subjective Downtime Assessment After Each Treatment Collected at Week 1 post-treatment follow-up visits for each treatment session. 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).