Effectiveness and Safety of the Ulthera® System for Skin Laxity in the Lower Face, Submentum and Neck
16 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Tipo de estudio
Intervencionista
Inscripción (Estimado)
218
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Public Disclosure Manager Merz Aesthetics
- Número de teléfono: +1 984-301-3095
- Correo electrónico: Aesthetic.Trials@merz.com
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100034
- Reclutamiento
- Merz Investigative Site
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Beijing, Beijing Municipality, Porcelana, 100730
- Reclutamiento
- Merz Investigative Site
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510317
- Reclutamiento
- Merz Investigative Site
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Jiangsu
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Nanjing, Jiangsu, Porcelana, 210003
- Reclutamiento
- Merz Investigative Site
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Shaanxi
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Xi'an, Shaanxi, Porcelana, 710004
- Reclutamiento
- Merz Investigative Site
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200040
- Reclutamiento
- Merz Investigative Site
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Shanghai, Shanghai Municipality, Porcelana, 200443
- Reclutamiento
- Merz Investigative Site
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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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Otro: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Merz Medical Expert, Merz North America, Inc.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
15 de junio de 2026
Finalización primaria (Estimado)
1 de diciembre de 2026
Finalización del estudio (Estimado)
1 de marzo de 2027
Fechas de registro del estudio
Enviado por primera vez
22 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
22 de mayo de 2026
Publicado por primera vez (Actual)
29 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
16 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ULT-LAX-CN002
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Sí
producto fabricado y exportado desde los EE. UU.
Sí
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .