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

Part of paid clinical trials in Houston, Texas.

Sponsor
FA Corporation
Study ID
NCT07222397
Status
Recruiting
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Conditions

  • Lines Skin
  • Photodamaged Skin
  • Rhytids
  • Wrinkles and Rhytides

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Laser Resurfacing — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Mar 1, 2025
Status verified
Oct 2025
Primary completion
Dec 31, 2025
Completion
Feb 28, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Part 2 Clinical Study Procedure
    UltraClear 2,910nm mid-infrared laser using both superficial epidermal ablation and deep ablative and coagulative capabilities in the dermis for rejuvenation addressing perioral lines and wrinkles.

Primary Outcome Measure

Change in Fitzpatrick Wrinkling and Degree of Elastosis Scale (FWS) [ Time Frame: From enrollment to the final follow-up visit (3-months following final treatment) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dermatology & Laser Surgery CenterHoustonTexas77030-

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Dermatology & Laser Surgery Center· Houston, TX

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