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Effectiveness and Safety of the Ulthera® System for Skin Laxity in the Lower Face, Submentum and Neck

16. juni 2026 oppdatert av: Merz North America, Inc.

Evaluation of the Effectiveness and Safety of the Ulthera® System for Treating Skin Laxity in the Lower Face, Submentum and Neck

The purpose of this study is to demonstrate superiority of treatment with the Ulthera System compared to untreated control for the improvement of skin laxity of the lower face, submental area and neck and to demonstrate the safety of treatment with the Ulthera System for the improvement of skin laxity of the lower face, submental area and neck.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

218

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

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100034
        • Rekruttering
        • Merz Investigative Site
      • Beijing, Beijing Municipality, Kina, 100730
        • Rekruttering
        • Merz Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510317
        • Rekruttering
        • Merz Investigative Site
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210003
        • Rekruttering
        • Merz Investigative Site
    • Shaanxi
      • Xi'an, Shaanxi, Kina, 710004
        • Rekruttering
        • Merz Investigative Site
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200040
        • Rekruttering
        • Merz Investigative Site
      • Shanghai, Shanghai Municipality, Kina, 200443
        • Rekruttering
        • Merz Investigative Site

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:

  • Mild to moderate lower face, submental and/or neck laxity, that is amenable to improvement with non-invasive intervention and not severe enough for surgical intervention.
  • Willing to abstain from all other aesthetic treatments on ANY part of the face, submentum or neck, including but not limited to injectable fillers, implants, neurotoxin, skin peels, laser treatments, surgical treatments, etc. for the clinical investigation's duration.
  • Willing and able to refrain from chronic use of aspirin, ibuprofen, naproxen, or other nonsteroidal anti-inflammatory drugs (NSAIDs) for 10 to 14 days post-treatment.
  • Has an adequate understanding of the Chinese language.
  • Willing and able to comply with protocol requirements.

Exclusion Criteria:

  • Scarring in area(s) to be treated.
  • Any active implants.
  • Any metallic implants in area(s) to be treated.
  • Any open wounds or lesions, including active herpes simplex, in the area(s) to be treated.
  • Presence of an active systemic or local skin disease, including active, cystic, or severe inflammatory acne in the area(s) to be treated.
  • History of keloid formation or hypertrophic scarring.

  • History of the following cosmetic treatments in area(s) to be treated:

    • Skin-tightening procedure,
    • Injectable crosslinked hyaluronic acid (HA)/collagen temporary dermal fillers of the lower face, submentum or neck within the past 12 months.
    • Injectable non-crosslinked HA dermal fillers of the lower face, submentum or neck within the past 6 months.
    • Injectable semi-permanent/permanent facial fillers
    • Neurotoxin treatment of the lower face, submentum or neck within the past 6 months.
    • Liposuction of the lower face, submentum or neck within the last 12 months.
    • Fat grafting of the lower face, submentum or neck within the last 12 months.
    • Deoxycholic acid within the last 12 months; and/or
    • Chemical peeling or dermabrasion treatments within the past 12 months.
    • Cryolipolysis
  • Had prior surgery in the lower-facial area and/or neck/submentum or has a permanent implant or graft in the lower-facial area that could interfere with effectiveness assessments.
  • Has undergone oral surgery in the past 30 days.
  • Participants who have used isotretinoin or other retinoid medications within 6 months prior to enrollment or have applied topical retinoid-containing medications on the face or neck area within 2 weeks prior to enrollment or planning such treatments during the study period.
  • Marked facial asymmetry, deep dermal scarring, or thick sebaceous skin in the full face.
  • Severe solar elastosis.
  • Facial nerve palsy or history of facial nerve palsy.
  • Tattoos in the area(s) to be treated (excluding microblading eyebrow).
  • Current smoker or history of smoking in the last 12 months.
  • Current daily user of any nicotine-containing products
  • Is a female of childbearing potential1 and not using medically effective birth control 2 or is pregnant, lactating, or planning to become pregnant during the clinical investigation.

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: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Treatment With Ulthera System
Participants randomized to receive a single treatment with Ulthera system to lower face, submentum and neck on Day 1.
Enhet: Ulthera System
Participants will receive treatment with the Ulthera system which consists of three primary components: the control unit, handpiece and interchangeable transducers.
Annen: Control/Delayed treatment With Ulthera System
Participants will remain untreated until Day 90 and then receive a single treatment with Ulthera system to lower face, submentum and neck.
Enhet: Ulthera System
Participants will receive treatment with the Ulthera system which consists of three primary components: the control unit, handpiece and interchangeable transducers.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of Participants With at Least "Improved" in Lower Face, Submental and Neck Skin Laxity on Global Aesthetic Improvement Scale as Determined by the Blinded Live Evaluator (eGAIS) at Day 90 Compared to Baseline Photographs
Tidsramme: Day 90
Blinded live evaluator will use eGAIS to evaluate global aesthetic improvement in the facial appearance of participants. The GAIS is a 5-point scale (1-5), where: 1(very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse). Higher scores indicate a worse outcome.
Day 90

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Three Independent, Blinded Raters GAIS (rGAIS) Score in Lower Face, Submental and Neck Skin Laxity at Day 90 Compared to Baseline Photographs
Tidsramme: Day 90
Three independent, blinded raters will use rGAIS to evaluate global aesthetic improvement in the facial appearance of participants. The GAIS is a 5-point scale (1-5), where: 1(very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse). Higher scores indicate a worse outcome.
Day 90
Treating Investigator's GAIS (iGAIS) Score in Lower Face, Submental and Neck Skin Laxity at Day 90 Compared to Baseline Photographs
Tidsramme: Day 90
Treating investigators will use the iGAIS to assess overall aesthetic improvement of the lower face, submentum, and neck. The GAIS is a 5-point scale (1-5), where: 1(very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse). Higher scores indicate a worse outcome. This outcome measure is prespecified for the Treatment Group only.
Day 90
Participant's GAIS (pGAIS) Scores in Lower Face, Submental Skin and Neck Laxity at Day 90 Compared to Baseline Photographs
Tidsramme: Day 90
Participants will self-report using the pGAIS to assess overall aesthetic improvement of the lower face, submentum, and neck. The pGAIS is a 5-point scale (1-5), where: 1(very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse). Higher scores indicate a worse outcome. This outcome measure is prespecified for the Treatment Group only.
Day 90

Samarbeidspartnere og etterforskere

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

Sponsor

Merz North America, Inc.

Samarbeidspartnere

Ulthera, Inc

Etterforskere

  • Studieleder: Merz Medical Expert, Merz North America, Inc.

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 (Faktiske)

15. juni 2026

Primær fullføring (Antatt)

1. desember 2026

Studiet fullført (Antatt)

1. mars 2027

Datoer for studieregistrering

Først innsendt

22. mai 2026

Først innsendt som oppfylte QC-kriteriene

22. mai 2026

Først lagt ut (Faktiske)

29. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ULT-LAX-CN002

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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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