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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)

9 augustus 2026 bijgewerkt door: FA Corporation
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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

50

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • Kentucky
      • Prospect, Kentucky, Verenigde Staten, 40059
        • Julene B Samuels MD, FACS
        • Contact:
        • Hoofdonderzoeker:
          • Julene B Samuels, MD, FACS
    • Texas
      • Houston, Texas, Verenigde Staten, 77004
        • Dermatology & Laser Surgery Center
        • Contact:
        • Hoofdonderzoeker:
          • Paul M Friedman, MD
        • Onderonderzoeker:
          • Emily Guo, MD
        • Onderonderzoeker:
          • Christina Lopez, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Apparaat: 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.
Andere namen:
  • 2910 nm erbium doped fluoride fiber glass laser
  • 2910 nm fractional ablative laser
  • 2910 nm fiber laser

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Quantitative 2D Photographic Analysis:
Tijdsspanne: 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).
Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)
Blinded Photographic Review
Tijdsspanne: 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.
Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Investigator Global Aesthetic Improvement Scale (iGAIS)
Tijdsspanne: Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment).
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)
Tijdsspanne: Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment).
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)
Tijdsspanne: Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)
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)
Tijdsspanne: Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)
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
Tijdsspanne: Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)
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)

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of Treatment Emergent Adverse Events and Discomfort Scores (Safety and Tolerability)
Tijdsspanne: Through the study, an average of 1 year

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

FA Corporation

Onderzoekers

  • Hoofdonderzoeker: Paul M Friedman, MD, Dermatology & Laser Surgery Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

7 augustus 2026

Primaire voltooiing (Geschat)

31 augustus 2027

Studie voltooiing (Geschat)

31 augustus 2027

Studieregistratiedata

Eerst ingediend

4 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

9 augustus 2026

Eerst geplaatst (Werkelijk)

12 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

9 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • UC 29-2026

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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