Skin Laxity (Submental and Neck)UC 29-2026NCT07759817
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
A study testing 2910 nm fiber laser (UltraClear®) in people with Skin Laxity (Submental and Neck) and Skin Lifting and Tightening, run by FA Corporation at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Laxity (Submental and Neck), Skin Lifting and Tightening
- What is being tested?
- 2910 nm fiber laser (UltraClear®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Aug 2026to 31 Aug 2027
- 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fitzpatrick skin types I-III participants with Fitzpatrick Skin Types IV-VI may be enrolled only at the investigator's discretion, based on individualized risk assessment documenting skin tone-related risk of post-inflammatory hyperpigmentation, wound healing history, and prior response to ablative or energy-based treatments. Risk assessment documentation must be retained in the participant's study file. Male or female.
- Participants must be between 35 and 65 years of age.
- Participants must have the ability to receive two lower face and full neck resurfacing laser treatments with desire for improvement in lifting and skin laxity.
- Participants must read, understand, and sign the Informed Consent Form.
- Participants must be willing and able to comply with all follow-up visit requirements.
- Participants must agree to refrain from using cosmeceutical agents or topical agents during the study, except as directed by study investigator.
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- Participants must be rated as (2) Moderate Sagging to (4) Very Severe Sagging based on the Merz Jawline Grading Scale (MJGS)[11].
- Participants must be rated as a (C) Grade 3: moderate laxity, (D) Grade 4: moderate to severe laxity or (E) Grade 5: severe laxity of the tissues of the neck based on the 5-Grade IBSA Neck Laxity Scale [12]
- Participants of childbearing potential must 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.
- Participants agree to maintain stable body weight, defined as no planned weight-loss program and no significant change in body weight (±10 lbs or ±5%) within 3 months prior to enrollment and throughout study participation.
- Participants identified as an appropriate candidate for study treatment based on principal investigator's opinion.
Who cannot join
- Participants must not have active localized or systemic infections.
- Participants 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.
- Participants must not be current smoker or have history of regular tobacco or nicotine use within 12 months prior to enrollment.
- Participants must not have had treatments with systemic steroids or systemic retinoids in the 4-months prior to enrollment.
- Participants must not have had treatments with 5FU, diclofenac, imiquimod or PDT within 1-month prior to enrollment.
- Participants must not have severe or cystic facial acne; currently taking Accutane or have taken Accutane within the last 1-month.
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- Participants must not have a known allergy to lidocaine or epinephrine, topical or injectable products containing lidocaine or any numbing medications.
- Participants must not have had previous surgery and/or fat transfer in the treatment area within the last 6-months.
- Participant must not have had injectable soft tissue fillers within the last 12-months in the treatment area.
- Participant must not have had Poly-L-Lactic acid (PLLA) or Calcium Hydroxylapatite (CaHA) fillers within the last 2 years in the treatment area.
- Participant must not have had permanent filler i.e., Polymethylmethacrylate (PMMA) in the treatment area.
- Participants must not have had neurotoxins within the last 4-months in the treatment area.
- Participant 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.
- Participant 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.
- Participant 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.
- Participants must not have a personal history of malignant melanoma, keloid scars, generalized psoriasis or systemic diseases that would preclude the use of topical anesthesia.
- Participant must not have active sunburn or excessively tanned skin.
- Participants must not be pregnant or planning to become pregnant, have given birth less than 3-months ago, and/or breastfeeding during the study. Participants of childbearing potential will be asked to confirm they are not pregnant at screening, at each treatment visit and at Visit 6: Day 139 ± 7 days (3-month follow-up) representing approximately 90 days following the second treatment and Visit 7: Day 229 ± 7 days (6-month follow-up).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Dermatology & Laser Surgery Center
Houston, Texas, 77004
Annie Li, 713-900-3900, research@dermlasersurgery.com
Paul M Friedman, MD
Julene B Samuels MD, FACS
Prospect, Kentucky, 40059
Heather Kushner, 502-806-8876, hkushner@awomanstouchmd.com
Julene B Samuels, MD, FACS
About this study
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.
- Being tested
- 2910 nm fiber laser (UltraClear®)
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2910 nm fiber laser (UltraClear®)Device
Also called 2910 nm erbium doped fluoride fiber glass laser, 2910 nm fractional ablative laser, 2910 nm fiber laser
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 group | Role | What they receive |
|---|---|---|
| 2910 nm fiber laser treatment | Experimental | 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. Receives: Device: 2910 nm fiber laser (UltraClear®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative 2D Photographic Analysis:
Proportion of participants achieving a ≥20 mm² reduction in submental area post treatment, measured by a blinded independent analyst using a five-point landmark methodology applied to standardized 2D photographs. The study-level responder rate must achieve statistical significance (p < 0.05).
Measured: Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)
Blinded Photographic Review
Proportion of participants for whom ≥2 of 3 Blinded Independent Photographic Reviewers (BIPRs) correctly identify post-treatment improvement from paired baseline and Visit 6 photographs of the submental and neck regions. Pre-specified responder threshold: ≥80% of evaluable participants.
Measured: Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)
Secondary outcomes (5)
Investigator Global Aesthetic Improvement Scale (iGAIS)
Range: 0-4 Directionality: higher score equates to better outcome (0= Worse, 1= No change, 2= Improved, 3= Much improved, 4= Very much improved). Proportion with any improvement from baseline.
Measured: Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment).
Investigator Merz Jawline Grading Scale (MJGS)
Range: 0-4 Directionality: lower score equates to better outcome (less sagging) (0= No sagging, 1= Mild sagging, 2= Moderate sagging, 3= Severe sagging, 4= Very severe sagging). Change from baseline will be assessed.
Measured: Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment).
Participant Global Aesthetic Improvement Scale (sGAIS)
Range: 0-4 Directionality: higher score equates to better outcome (0= Worse, 1= No change, 2= Improved, 3= Much improved, 4= Very much improved). Proportion with any improvement from baseline.
Measured: Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)
FACE-Q™ Satisfaction with Lower Face and Jawline (Rasch-transformed score)
Range: 1-4, Directionality: higher score equates to increased satisfaction (1= Very dissatisfied, 2= Somewhat dissatisfied, 3= Somewhat satisfied, 4= Very satisfied). Change from baseline will be assessed.
Measured: Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)
Participant satisfaction questionnaire
Range: 1-4 Directionality: higher score equates to increased satisfaction (1= very dissatisfied, 2= Dissatisfied, 3= Satisfied, 4= Very satisfied). Satisfaction questionnaire completed by participant following two 2910 nm fiber laser treatments.
Measured: Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start7 Aug 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Laxity (Submental and Neck)Studies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FA Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul M Friedman, MD, Principal investigator, Dermatology & Laser Surgery Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759817
- Sponsor's protocol ID
- UC 29-2026
- Acronym
- UC 29-2026
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07759817
- Acronym / sponsor ID
- UC 29-2026 / UC 29-2026
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- FA CorporationIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 12 Aug 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2910 nm fiber laser treatment | Experimental | Device: 2910 nm fiber laser (UltraClear®)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. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Fitzpatrick skin types I-III participants with Fitzpatrick Skin Types IV-VI may be enrolled only at the investigator's discretion, based on individualized risk assessment documenting skin tone-related risk of post-inflammatory hyperpigmentation, wound healing history, and prior response to ablative or energy-based treatments. Risk assessment documentation must be retained in the participant's study file. Male or female.
- Participants must be between 35 and 65 years of age.
- Participants must have the ability to receive two lower face and full neck resurfacing laser treatments with desire for improvement in lifting and skin laxity.
- Participants must read, understand, and sign the Informed Consent Form.
- Participants must be willing and able to comply with all follow-up visit requirements.
Key exclusion criteria (18 listed)
- Participants must not have active localized or systemic infections.
- Participants 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.
- Participants must not be current smoker or have history of regular tobacco or nicotine use within 12 months prior to enrollment.
- Participants must not have had treatments with systemic steroids or systemic retinoids in the 4-months prior to enrollment.
- Participants 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 |
|---|---|---|
| 2910 nm fiber laser (UltraClear®)Also: 2910 nm erbium doped fluoride fiber glass laser, 2910 nm fractional ablative laser, 2910 nm fiber laserUltraClear® 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. | Device | 2910 nm fiber laser treatment |
Primary outcome
Quantitative 2D Photographic Analysis:
Time frame: Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)
Proportion of participants achieving a ≥20 mm² reduction in submental area post treatment, measured by a blinded independent analyst using a five-point landmark methodology applied to standardized 2D photographs. The study-level responder rate must achieve statistical significance (p < 0.05).
Blinded Photographic Review
Time frame: Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)
Proportion of participants for whom ≥2 of 3 Blinded Independent Photographic Reviewers (BIPRs) correctly identify post-treatment improvement from paired baseline and Visit 6 photographs of the submental and neck regions. Pre-specified responder threshold: ≥80% of evaluable participants.
5 secondary outcomes
Investigator Global Aesthetic Improvement Scale (iGAIS)
Time frame: Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment).
Investigator Merz Jawline Grading Scale (MJGS)
Time frame: Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment).
Participant Global Aesthetic Improvement Scale (sGAIS)
Time frame: Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)
FACE-Q™ Satisfaction with Lower Face and Jawline (Rasch-transformed score)
Time frame: Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)
Participant satisfaction questionnaire
Time frame: Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second 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 12 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Paul M Friedman, MD principal investigator
Dermatology & Laser Surgery Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2910 nm fiber laser (UltraClear®) in people with Skin Laxity (Submental and Neck) and Skin Lifting and Tightening, run by FA Corporation at 2 sites 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 11 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: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Paul M Friedman, MD (713-900-3900, research@dermlasersurgery.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative 2D Photographic Analysis: (time frame: Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)). The study lists 2 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 12 Aug 2026.