Safety and Efficacy of a 2,910 nm Fractional Ablative Fiber Laser (UltraClear®) for Improvements of Skin Laxity and Lifting of the Lower Face, Submental, and Neck Treatment Areas

Part of paid clinical trials in Prospect, Kentucky.

Sponsor
FA Corporation
Study ID
NCT07759817
Status
Not Yet Recruiting

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Conditions

  • Skin Laxity (Submental and Neck)
  • Skin Lifting and Tightening

Eligibility Criteria

Sex
ALL
Age
35 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • 2910 nm fiber laser (UltraClear®) — DEVICE
    UltraClear® is a 2,910 nm fractional ablative erbium-doped fluoride glass fiber laser (Acclaro), FDA 510(k) cleared (K210847, K233803) for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. In this study, it is applied to the lower face, submental region, and neck using fractional ablative resurfacing, laser-coring, and full ablative resurfacing configurations, with mode and parameters selected by the investigator based on baseline anatomy and tissue laxity.

Study Details

This study evaluates the safety and effectiveness of the UltraClear® 2,910 nm fractional ablative fiber laser for improving skin laxity and tissue lifting in the lower face, submental, and neck areas. Up to 50 adults ages 35-65 will receive two laser treatments approximately 7 weeks apart at two clinical sites. Outcomes will be assessed approximately 90 days after the second treatment using photographic analysis and investigator- and participant-reported improvement scales.

Key Dates

First listed
Aug 12, 2026
Start date
Aug 7, 2026
Status verified
Aug 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

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

Arms

  • Experimental: 2910 nm fiber laser treatment
    Participants receive two treatments with the UltraClear® 2,910 nm fractional ablative fiber laser to the lower face, submental region, and neck, spaced approximately 7 weeks (±7 days) apart.

Primary Outcome Measure

Quantitative 2D Photographic Analysis: [ Time Frame: Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Julene B Samuels MD, FACSProspectKentucky40059
Heather Kushner
[email protected]
502-806-8876
Julene B Samuels, MD, FACS (PRINCIPAL_INVESTIGATOR)
Dermatology & Laser Surgery CenterHoustonTexas77004
Annie Li
[email protected]
713-900-3900
Paul M Friedman, MD (PRINCIPAL_INVESTIGATOR)
Emily Guo, MD (SUB_INVESTIGATOR)
Christina Lopez, MD (SUB_INVESTIGATOR)

Find similar trials in Prospect, KY

By research site
Julene B Samuels MD, FACS· Prospect, KYDermatology & Laser Surgery Center· Houston, TX

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