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

Launched by LASER TEAM LTD · Aug 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new laser device called Epicare to see if it is safe and effective for treating moderate to severe wrinkles around the eyes in adults aged 25 to 65. The goal is to improve the appearance of these wrinkles, and researchers will carefully evaluate how well the treatment works by comparing photos taken before and after the procedure. Up to 50 people will take part, and most will receive one laser treatment, with a possible second treatment two months later if needed. Follow-up visits will happen over the next several months to check the results and monitor safety.

To join the study, participants should be generally healthy adults between 25 and 65 years old who have noticeable wrinkles around both eyes that are about the same on each side. People with certain health conditions, recent facial cosmetic treatments, or who are pregnant or planning to become pregnant will not be eligible. During the study, participants will need to avoid other wrinkle treatments and follow all instructions, including attending follow-up visits and allowing standardized photos to be taken. The study will also ask about participants’ satisfaction, any pain experienced, and any downtime after treatment. Safety is a top priority, and any side effects related to the device will be closely tracked.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.