ClinicalTrials.gg
Active, not recruitingNCT07254884Updated Sep 1, 2026

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

An interventional study of 2,910 nm mid-infrared erbium-doped fluoride fiber glass laser (UltraClear, Acclaro Medical) in Rhytids and Skin Laxity, sponsored by FA Corporation. Active, not recruiting at 1 site in United States. Open to participants aged 45 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by FA Corporation · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
45 Years to 85 Years
Sex
All
01

Study summary

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).

02

Conditions studied

  • Rhytids
  • Skin Laxity

Keywords

  • Eyebrow Lift
  • Submental Tissue Lift
  • Wrinkles
  • Rhytids
03

In context

Lead sponsor

FA Corporation is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 have been on an acceptable form of for 30 days prior to enrollment and agree to continue using throughout the course of the study

Exclusion criteria

Exclusion Criteria:

  • Subjects must not have active localized or systemic infections
  • Subjects must not have a compromised ability for wound healing, such as: malnutrition, 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • 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)

Interventions

  • Device2,910 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.

06

What researchers measure

Primary outcomes

  1. Objective measurement of maximal eyebrow lift according to quantitative 2D imaging.

    Time frame: Six months following final treatment

  2. 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.

    Time frame: Six months following final treatment

  3. ○ Objective measurement of lax submental tissue lift according to quantitative 2D imaging.

    Time frame: Six months following final treatment

Secondary outcomes

  1. 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

    Time frame: Six months following final treatment

  2. 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

    Time frame: Six months following final treatment

Other outcomes

  1. 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

    Time frame: Periprocedural and 15 minutes post-procedure

07

Study locations

1 site
  • Schweiger Dermatology
    Edina, Minnesota 55424, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2025 (actual). Primary completion is estimated for Nov 2026, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 1, 2025
First posted
Nov 28, 2025
StartActual
Nov 24, 2025
Primary completionEst.
Nov 2026
CompletionEst.
Nov 2026
Last update
Sep 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07254884
Lead sponsor
FA Corporation
Responsible party
Sponsor
First posted
Nov 28, 2025
Start date
Nov 24, 2025
Primary completion
Nov 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
Sep 1, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion