Periorbital WrinklesNCT07114562
Evaluation of the Safety and Performance of Epicare for the Treatment of Periorbital Wrinkles
A study testing Epicare in people with Periorbital Wrinkles, run by Laser team Ltd.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periorbital Wrinkles
- What is being tested?
- Epicare
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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
- Being tested
- Epicare
- Keywords
- Wrinkles; Periorbital wrinkles; Aesthetic dermatology; Laser resurfacing; Fractional thulium laser; Epicare
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpicareDevice
All participants will receive treatment with the Epicare fractional nano-thulium (Tm:YAP, 1938 nm) laser device for the reduction of periorbital wrinkles.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Epicare |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months post-Treatment #2
Secondary outcomes (6)
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).
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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).
Measured: Collected at Week 1 post-treatment follow-up visits for each treatment session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start30 Mar 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periorbital WrinklesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laser team Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoav Gronovich, Dr., Principal investigator, Shaare Zedek Medical CenterAvshalom Shalom, Prof., Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114562
- Sponsor's protocol ID
- PL-001
- Status last verified
- Nov 2025
- First submitted
- 3 Aug 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07114562
- Acronym / sponsor ID
- PL-001
- Conditions
- Periorbital Wrinkles
- Keywords
- Wrinkles; Periorbital wrinkles; Aesthetic dermatology; Laser resurfacing; Fractional thulium laser; Epicare
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Laser team LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Epicare treatment arm | Experimental | Device: EpicareAll participants will receive treatment with the Epicare fractional nano-thulium (Tm:YAP, 1938 nm) laser device for the reduction of periorbital wrinkles. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpicareAll participants will receive treatment with the Epicare fractional nano-thulium (Tm:YAP, 1938 nm) laser device for the reduction of periorbital wrinkles. | Device | Epicare treatment arm |
Primary outcome
Fitzpatrick Wrinkle Classification Scale (FWCS) improvement after three months from last treatment.
Time frame: 3 months post-Treatment #2
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.
6 secondary outcomes
Physician-Reported GAIS Improvement
Time frame: 3 months post-Treatment #2
Physician-Reported FWCS Improvement
Time frame: 3 months post-Treatment #2
Subject-Reported GAIS
Time frame: 3 months post-Treatment #2
Subject-Reported S-GSQ
Time frame: 3 months post-Treatment #2
Pain Assessment Using Visual Analog Scale (VAS) After Each Treatment
Time frame: Immediately post-procedure at each treatment visit
Subjective Downtime Assessment After Each Treatment
Time frame: Collected at Week 1 post-treatment follow-up visits for each treatment session.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No
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Performance and Safety of Semical Dermal Fillers in Facial Rejuvenation
Facial Aging, Skin Rejuvenation
Enrolling by invitation
Non-invasive Rejuvenation of the Periorbital Area and Lower Eyelid
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yoav Gronovich, Dr. principal investigator
Shaare Zedek Medical Center
Avshalom Shalom, Prof. principal investigator
Meir Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Epicare in people with Periorbital Wrinkles, run by Laser team Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pini Ben Elazar (+972-52-3447333, pinib@lasertm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fitzpatrick Wrinkle Classification Scale (FWCS) improvement after three months from last treatment. (time frame: 3 months post-Treatment #2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.