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2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the Treatment of Advanced Perioral Lines and Wrinkles
Sponsor: FA Corporation
Summary
The primary objective is to assess the efficacy, safety and satisfaction associated with the resurfacing treatment of perioral lines and wrinkles with the 2,910 nm mid-infrared Fiber Laser (UltraClear, Acclaro Medical) using both superficial epidermis ablation capabilities and the deep ablative and coagulative capabilities into the dermis for rejuvenation. Participants will receive up to two treatments spaced 6-8 weeks apart, followed by a 1-month and 3-month follow-up visit during which the device will be evaluated for its effectiveness defined as improvement addressing perioral lines and wrinkles utilizing multiple scales completed by the investigator and blinded Independent Photographic Reviewers (IPRs). Additionally, safety, subjective overall aesthetic improvement and satisfaction will be monitored and tracked.
Official title: Evaluation of the 2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the Treatment of Advanced Perioral Lines and Wrinkles
Key Details
Gender
All
Age Range
50 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-03-01
Completion Date
2026-02
Last Updated
2025-10-29
Healthy Volunteers
No
Interventions
Laser Resurfacing
Enrolled participants will be treated with the UltraClear 2,910nm mid-infrared laser using both superficial epidermal ablation and deep ablative and coagulative capabilities in the dermis for rejuvenation with a specific focus on perioral lines and wrinkles.
Locations (1)
Dermatology & Laser Surgery Center
Houston, Texas, United States