RhytidsNCT07254884
Safety and Efficacy of 2910 nm Fiber Laser Resurfacing and Laser-Coring
A study testing 2,910 nm mid-infrared erbium-doped fluoride fiber glass laser (UltraClear, Acclaro Medical) in people with Rhytids and Skin Laxity, run by FA Corporation at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Rhytids, Skin Laxity
- What is being tested?
- 2,910 nm mid-infrared erbium-doped fluoride fiber glass laser (UltraClear, Acclaro Medical)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Rhytids, Skin Laxity
- Being tested
- 2,910 nm mid-infrared erbium-doped fluoride fiber glass laser (UltraClear, Acclaro Medical)
- Keywords
- Eyebrow Lift, Submental Tissue Lift, Wrinkles, Rhytids
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2,910 nm mid-infrared erbium-doped fluoride fiber glass laser (UltraClear, Acclaro Medical)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Laser Treatment Arm | Experimental | 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 Receives: Device: 2,910 nm mid-infrared erbium-doped fluoride fiber glass laser (UltraClear, Acclaro Medical) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective measurement of maximal eyebrow lift according to quantitative 2D imaging.
Measured: 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.
Measured: Six months following final treatment
○ Objective measurement of lax submental tissue lift according to quantitative 2D imaging.
Measured: Six months following final treatment
Secondary outcomes (2)
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
Measured: 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
Measured: Six months following final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start24 Nov 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhytidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FA Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254884
- Sponsor's protocol ID
- UC 28-2025
- Status last verified
- Aug 2026
- First submitted
- 1 Oct 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07254884
- Acronym / sponsor ID
- UC 28-2025
- Conditions
- Rhytids, Skin Laxity
- Keywords
- Eyebrow Lift, Submental Tissue Lift, Wrinkles, Rhytids
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- FA CorporationIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser Treatment Arm | Experimental | 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 |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Laser Treatment Arm |
Primary outcome
Objective measurement of maximal eyebrow lift according to quantitative 2D imaging.
Time frame: Six months following final treatment
Blinded Photographic Review
Time frame: Six months following final treatment
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.
○ Objective measurement of lax submental tissue lift according to quantitative 2D imaging.
Time frame: Six months following final treatment
2 secondary outcomes
Physician rating on the Global Aesthetic Improvement Scale (PGAIS)
Time frame: Six months following final treatment
Subjects rating on the Subject Global Aesthetic Improvement Scale & Satisfaction Questionnaire (SGAIS)
Time frame: Six months following final treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2,910 nm mid-infrared erbium-doped fluoride fiber glass laser (UltraClear, Acclaro Medical) in people with Rhytids and Skin Laxity, run by FA Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective measurement of maximal eyebrow lift according to quantitative 2D imaging. (time frame: Six months following final treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.