Safety and Efficacy of 2910 nm Fiber Laser Resurfacing and Laser-Coring

Safety and Efficacy of 2910 nm Fiber Laser Resurfacing and Laser-Coring Treatment to Lift the Eyebrow, Submental Lax Tissue and Address Advanced Signs of Facial Aging

The primary objective of this clinical trial is to evaluate the safety and effectiveness of the 2,910 nm mid-infrared erbium-doped fluoride fiber glass laser (UltraClear, Acclaro Medical) for non-invasive dermatological aesthetic treatment of three facial regions: eyebrow lift (Region 1), submental tissue lift (Region 2), and improvement of rhytids and skin laxity in the cheeks, midface, and jawline (Region 3).

Study Overview

• Status: Not yet recruiting
• Conditions: Skin Laxity; Rhytids
• Intervention / Treatment: Device: 2,910 nm mid-infrared erbium-doped fluoride fiber glass laser (UltraClear, Acclaro Medical)

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Fitzpatrick skin type I-VI
• Male or female
• Subjects must be between 45 and 85 years of age
• Subjects must have the ability to receive two and up to three full face and upper neck resurfacing laser treatments (pending PI discretion) with desire to lift facial lax skin, submental and/or to lift the eyebrow area and/or improve facial wrinkles appearance
• Subjects must read, understand, and sign the Informed Consent Form
• Subjects must be willing and able to comply with all follow-up visit requirements
• Subjects must agree to refrain from using cosmeceutical agents or topical agents during the study, except as directed by study investigator
• Subjects must be rated as (2) Moderate Sagging to (4) Very Severe Sagging based on the Merz Scale: Jawline at Rest
• Subject identified as an appropriate candidate for study treatment based on principal investigator's opinion
• Subjects of childbearing potential have been on an acceptable form of contraception for 30 days prior to enrollment and agree to continue using throughout the course of the study

Exclusion Criteria:

• Subjects must not have active localized or systemic infections
• Subjects must not have a compromised ability for wound healing, such as: malnutrition, steroid use, history of collagen vascular disease (e.g., lupus, scleroderma, history of keloid scar formation), atopic dermatitis or immunologic abnormalities such as vitiligo
• Subjects must not be current smoker or have significant history of smoking
• Subjects must not have had treatments with systemic steroids or systemic retinoids in the 4-months prior to enrollment
• Subjects must not have had treatments with 5FU, diclofenac, imiquimod or PDT within 1-month prior to enrollment
• Subjects must not have severe or cystic facial acne; currently taking Accutane or have taken Accutane within the last 1-month
• Subjects must not have a known allergy to lidocaine or epinephrine, topical or injectable products containing lidocaine or any numbing medications
• Subjects must not have had previous surgery and/or fat transfer in the treatment area within the last 6-months
• Subject must not have had injectable soft tissue fillers within the last 12 months in the treatment area
• Subject must not have had Poly-L-Lactic acid (PLLA) fillers within the last 2 years in the treatment area
• Subject must not have had permanent filler i.e., Polymethylmethacrylate (PMMA) in the treatment area
• Subjects must not have had neurotoxins within the last 4-months in the treatment area
• Subject must not have a personal history of any facial threads i.e., PDO (Polydioxanone), PLLA (Polylactic acid), PCL (Polycaprolactone) in the treatment area within the last 12-months
• Subject must not have had a pulse dye or vascular laser, non-ablative laser, microneedling or RF microneedling treatments in the treatment area within the last 3-months
• Subject must not have had an ultrasound treatment such as HIFU, monopolar RF energy-based devices, ablative laser treatments in the treatment area within the last 6-months
• Subjects must not have a personal history of malignant melanoma, keloid scars, generalized psoriasis or systemic diseases that would preclude the use of topical anesthesia
• Subject must not have active sunburn or excessively tanned skin
• Subjects must not be pregnant or planning to become pregnant, have given birth less than 3 months ago, and/or breastfeeding during the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser Treatment Arm; Enrolled subjects will receive a series of two with an optional third 2,910 nm Fiber Laser treatments using fractional ablative resurfacing modes, laser-coring and full ablation addressing the full face and upper neck	Device: 2,910 nm mid-infrared erbium-doped fluoride fiber glass laser (UltraClear, Acclaro Medical); Enrolled subjects will receive a series of two with an optional third 2,910 nm Fiber Laser treatments using fractional ablative resurfacing modes, laser-coring and full ablation addressing the full face and upper neck.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective measurement of maximal eyebrow lift according to quantitative 2D imaging.		Six months following final treatment
Blinded Photographic Review	Blinded independent photographic review correct identification of pre-post image sequence for eyebrow lift, submental lift and improvement of lax skin in the lower face and submentum.	Six months following final treatment
○ Objective measurement of lax submental tissue lift according to quantitative 2D imaging.		Six months following final treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician rating on the Global Aesthetic Improvement Scale (PGAIS)	Physician graded aesthetic improvement, scored from photographs. Scale 0 - 4 with 4 being the most improved and 0 being worse than the original condition. 4 - Very much improved, optimal cosmetic result, very significant improvement 3 - Much improved, market improvement in appearance from the initial condition, but not completely optimal, marked 2 - Improved, obvious improvement in appearance from the initial condition, but a pretreatment is needed, moderate 1 - No change, the appearance is essential the same as the original condition in appearance from he initial condition 0 - Worse, the appearance is worse than the original condition, no improvement	Six months following final treatment
Subjects rating on the Subject Global Aesthetic Improvement Scale & Satisfaction Questionnaire (SGAIS)	Subjects rate their perceived improvement of the treatment area on a 5 point scale. 4- Very Much Improved, optimal cosmetic result, very significant improvement 3 - Much Improved, marked improvement in appearance from he initial condition but not completely optimal, marked 2 - Improved, obvious improvement in appearance from the initial condition, but a re-treatment is needed, moderate 1 - No change, the appearance is essentially the same as the original condition in appearance from the initial condition 0 - Worse, the appearance is worse than the original condition, no improvement	Six months following final treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the pain and discomfort after treatment as reported by the subject on a visual analog scale (VAS)	VAS is a 10 point scale, reported by the subject. Subjects will be asked to report on a scale of 0-10, the average level of discomfort experienced during treatment. 0 - No Pain 5 - Moderate Pain 10 - Unbearable Pain	Periprocedural and 15 minutes post-procedure

Collaborators and Investigators

• Sponsor: FA Corporation

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: October 1, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Actual): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Wrinkles; Rhytids; Eyebrow Lift; Submental Tissue Lift
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Connective Tissue Diseases; Skin Diseases; Skin Diseases, Genetic; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Cutis Laxa
• Other Study ID Numbers: UC 28-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No