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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. august 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Kentucky
      • Prospect, Kentucky, Forente stater, 40059
        • Julene B Samuels MD, FACS
        • Ta kontakt med:
        • Hovedetterforsker:
          • Julene B Samuels, MD, FACS
    • Texas
      • Houston, Texas, Forente stater, 77004
        • Dermatology & Laser Surgery Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Paul M Friedman, MD
        • Underetterforsker:
          • Emily Guo, MD
        • Underetterforsker:
          • Christina Lopez, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: 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.
Andre navn:
  • 2910 nm erbium doped fluoride fiber glass laser
  • 2910 nm fractional ablative laser
  • 2910 nm fiber laser

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Quantitative 2D Photographic Analysis:
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Investigator Global Aesthetic Improvement Scale (iGAIS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of Treatment Emergent Adverse Events and Discomfort Scores (Safety and Tolerability)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

FA Corporation

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

7. august 2026

Primær fullføring (Antatt)

31. august 2027

Studiet fullført (Antatt)

31. august 2027

Datoer for studieregistrering

Først innsendt

4. august 2026

Først innsendt som oppfylte QC-kriteriene

9. august 2026

Først lagt ut (Faktiske)

12. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • UC 29-2026

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Ja

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