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 (UC 29-2026)

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 Overview

• Status: Not yet recruiting
• Conditions: Skin Lifting and Tightening; Skin Laxity (Submental and Neck)
• Intervention / Treatment: Device: 2910 nm fiber laser (UltraClear®)

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paul M Friedman, MD; Phone Number: 713-900-3900; Email: research@dermlasersurgery.com

Study Locations

• United States
  • Kentucky
    • Prospect, Kentucky, United States, 40059
      • Julene B Samuels MD, FACS
      • Contact: Heather Kushner; Phone Number: 502-806-8876; Email: hkushner@awomanstouchmd.com
      • Principal Investigator: Julene B Samuels, MD, FACS
  • Texas
    • Houston, Texas, United States, 77004
      • Dermatology & Laser Surgery Center
      • Contact: Annie Li; Phone Number: 713-900-3900; Email: research@dermlasersurgery.com
      • Principal Investigator: Paul M Friedman, MD
      • Sub-Investigator: Emily Guo, MD
      • Sub-Investigator: Christina Lopez, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 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.
2. Participants must be between 35 and 65 years of age.
3. 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.
4. Participants must read, understand, and sign the Informed Consent Form.
5. Participants must be willing and able to comply with all follow-up visit requirements.
6. Participants must agree to refrain from using cosmeceutical agents or topical agents during the study, except as directed by study investigator.
7. Participants must be rated as (2) Moderate Sagging to (4) Very Severe Sagging based on the Merz Jawline Grading Scale (MJGS)[11].
8. 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]
9. 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.
10. 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.
11. Participants identified as an appropriate candidate for study treatment based on principal investigator's opinion.

Exclusion Criteria:

1. Participants must not have active localized or systemic infections.
2. 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.
3. Participants must not be current smoker or have history of regular tobacco or nicotine use within 12 months prior to enrollment.
4. Participants must not have had treatments with systemic steroids or systemic retinoids in the 4-months prior to enrollment.
5. Participants must not have had treatments with 5FU, diclofenac, imiquimod or PDT within 1-month prior to enrollment.
6. Participants must not have severe or cystic facial acne; currently taking Accutane or have taken Accutane within the last 1-month.
7. Participants must not have a known allergy to lidocaine or epinephrine, topical or injectable products containing lidocaine or any numbing medications.
8. Participants must not have had previous surgery and/or fat transfer in the treatment area within the last 6-months.
9. Participant must not have had injectable soft tissue fillers within the last 12-months in the treatment area.
10. Participant must not have had Poly-L-Lactic acid (PLLA) or Calcium Hydroxylapatite (CaHA) fillers within the last 2 years in the treatment area.
11. Participant must not have had permanent filler i.e., Polymethylmethacrylate (PMMA) in the treatment area.
12. Participants must not have had neurotoxins within the last 4-months in the treatment area.
13. 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.
14. 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.
15. 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.
16. 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.
17. Participant must not have active sunburn or excessively tanned skin.
18. 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).

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: 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.

Device: 2910 nm fiber laser (UltraClear®); 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.; Other Names: 2910 nm erbium doped fluoride fiber glass laser; 2910 nm fractional ablative laser; 2910 nm fiber laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment Emergent Adverse Events and Discomfort Scores (Safety and Tolerability)	Participant-rated discomfort via visual analog scale (VAS) will be completed following each 2910 nm fiber laser treatment. Range: 0-10 Directionality: lower score equates to less discomfort (ie. 0= No pain, 5= Moderate Pain, 10 = Worst Pain). Evaluations of Post Treatment Responses & Adverse Events to be completed by Investigator immediately post-treatment and at at each follow-up visit. Additionally device- and procedure-related adverse as well as unrelated event monitoring to be completed throughout the study.	Through the study, an average of 1 year

Collaborators and Investigators

• Sponsor: FA Corporation
• Investigators: Principal Investigator: Paul M Friedman, MD, Dermatology & Laser Surgery Center

Study record dates

Study Major Dates

• Study Start (Estimated): August 7, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: August 4, 2026
• First Submitted That Met QC Criteria: August 9, 2026
• First Posted (Actual): August 12, 2026

Study Record Updates

• Last Update Posted (Actual): August 12, 2026
• Last Update Submitted That Met QC Criteria: August 9, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• 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 29-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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