2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the Treatment of Advanced Perioral Lines and Wrinkles

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.

NCT Number	NCT07222397
Lead Sponsor	FA Corporation
Conditions	Photodamaged Skin, Rhytids, Lines Skin, Wrinkles and Rhytides
Enrollment	20 participants
Start Date	2025-03-01
Primary Completion	2025-12 (estimated)
Study Completion	2026-02 (estimated)
Updated on ClinicalTrials.gov	2025-10-29