Effectiveness and Safety of the Ulthera® System for Skin Laxity in the Lower Face, Submentum and Neck
16 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Type d'étude
Interventionnel
Inscription (Estimé)
218
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Public Disclosure Manager Merz Aesthetics
- Numéro de téléphone: +1 984-301-3095
- E-mail: Aesthetic.Trials@merz.com
Lieux d'étude
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Beijing Municipality
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Beijing, Beijing Municipality, Chine, 100034
- Recrutement
- Merz Investigative Site
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Beijing, Beijing Municipality, Chine, 100730
- Recrutement
- Merz Investigative Site
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Guangdong
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Guangzhou, Guangdong, Chine, 510317
- Recrutement
- Merz Investigative Site
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Jiangsu
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Nanjing, Jiangsu, Chine, 210003
- Recrutement
- Merz Investigative Site
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Shaanxi
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Xi'an, Shaanxi, Chine, 710004
- Recrutement
- Merz Investigative Site
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Chine, 200040
- Recrutement
- Merz Investigative Site
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Shanghai, Shanghai Municipality, Chine, 200443
- Recrutement
- Merz Investigative Site
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Treatment With Ulthera System
Participants randomized to receive a single treatment with Ulthera system to lower face, submentum and neck on Day 1.
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Participants will receive treatment with the Ulthera system which consists of three primary components: the control unit, handpiece and interchangeable transducers.
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Autre: 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.
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Participants will receive treatment with the Ulthera system which consists of three primary components: the control unit, handpiece and interchangeable transducers.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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
Délai: Day 90
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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.
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Day 90
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Three Independent, Blinded Raters GAIS (rGAIS) Score in Lower Face, Submental and Neck Skin Laxity at Day 90 Compared to Baseline Photographs
Délai: Day 90
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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.
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Day 90
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Treating Investigator's GAIS (iGAIS) Score in Lower Face, Submental and Neck Skin Laxity at Day 90 Compared to Baseline Photographs
Délai: Day 90
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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.
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Day 90
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Participant's GAIS (pGAIS) Scores in Lower Face, Submental Skin and Neck Laxity at Day 90 Compared to Baseline Photographs
Délai: Day 90
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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.
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Day 90
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Merz Medical Expert, Merz North America, Inc.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
15 juin 2026
Achèvement primaire (Estimé)
1 décembre 2026
Achèvement de l'étude (Estimé)
1 mars 2027
Dates d'inscription aux études
Première soumission
22 mai 2026
Première soumission répondant aux critères de contrôle qualité
22 mai 2026
Première publication (Réel)
29 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
16 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ULT-LAX-CN002
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Oui
produit fabriqué et exporté des États-Unis.
Oui
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .