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

16 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

218

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

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

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:

  • 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.

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: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Treatment With Ulthera System
Participants randomized to receive a single treatment with Ulthera system to lower face, submentum and neck on Day 1.
Apparaat: Ulthera System
Participants will receive treatment with the Ulthera system which consists of three primary components: the control unit, handpiece and interchangeable transducers.
Ander: 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.
Apparaat: Ulthera System
Participants will receive treatment with the Ulthera system which consists of three primary components: the control unit, handpiece and interchangeable transducers.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Three Independent, Blinded Raters GAIS (rGAIS) Score in Lower Face, Submental and Neck Skin Laxity at Day 90 Compared to Baseline Photographs
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

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

Sponsor

Merz North America, Inc.

Medewerkers

Ulthera, Inc

Onderzoekers

  • Studie directeur: Merz Medical Expert, Merz North America, Inc.

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 (Werkelijk)

15 juni 2026

Primaire voltooiing (Geschat)

1 december 2026

Studie voltooiing (Geschat)

1 maart 2027

Studieregistratiedata

Eerst ingediend

22 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

22 mei 2026

Eerst geplaatst (Werkelijk)

29 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

16 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ULT-LAX-CN002

Plan Individuele Deelnemersgegevens (IPD)

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

NEE

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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