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MFU-V superficial e hidroxiapatita de cálcio diluída para melhorar a qualidade da pele e rugas da face inferior

3 de novembro de 2026 atualizado por: Cutis Medical Laser Clinics Pte Ltd

This single-center pilot study evaluated whether one treatment session combining superficial microfocused ultrasound with visualization (MFU-V, Ultherapy, 1.5 mm transducer) and diluted calcium hydroxylapatite (CaHA, Radiesse, diluted 1:1 with saline and injected in the subdermal plane with a cannula) improves lower face skin quality and fine wrinkles in women aged 35 to 60 years.

Participants received a single combined treatment and were followed for 24 weeks, with assessments at baseline and at 4, 12 and 24 weeks after treatment. Skin surface texture and wrinkle dimensions were measured with the Quantificare LifeViz Micro 3D imaging system. Secondary assessments included wrinkle grading on the Modified Fitzpatrick Wrinkle Scale, visual aesthetic improvement, participant satisfaction, and treatment-related adverse events.

Visão geral do estudo

Descrição detalhada

Aging, genetics and environmental factors contribute to multiple changes on the surface of the skin. These present with pigmentation, volume loss, loss of elasticity and loss of collagen. Altogether, areas of the face becomes "crepey", with resulting rhytids and an obvious appearance of thin and fragile skin. These are typically dermal manifestations of elastin and collagen loss resulting in a collective term of loss of "skin quality".

Current treatments to improve these changes involve the use of skincare, chemical peels, as well as more invasive repeated treatments such as microneedling and laser resurfacing. These commonly require repeated treatments and several days of downtime. More recently, treatment with a hybrid preparation of high and low-molecular weight complexes that are thermally cross-linked (Profhilo) has been suggested to stimulate collagen and elastin formation, thereby resulting in improvement in skin quality However, the evidence for this remains limited. Microfocused Ultrasound with Visualization (MFU-V) and Calcium hydroxylapatite (CaHA) have each been unequivocally proven to stimulate neocollagenesis and elastogenesis, leading to improvement in skin laxity. A recent study of a single-treatment single-depth of superficial MFU-V was found to result in aesthetic improvement of the accordion lines. In addition, there is recent evidence that CaHA in a hyperdiluted form can stimulate collagen and elastin formation. Indeed, this group of investigators has recently published the effectiveness of a single treatment of a combination MFU-V and diluted CaHA for improving brachial skin laxity. Arguably, there is a need to publish additional studies on these interventions for improving firmness and skin quality. In addition, there may be a theoretical cumulative benefit in using both treatments for improving skin quality, although the effectiveness of this combination has not been demonstrated.

With this background, the main rationale of performing this study is to demonstrate the safety and efficacy of a multimodality approach with a single treatment of superficial MFU-V and diluted CaHA for improvement of skin quality in Asian and Caucasian patients. The investigators selected Lower Face as the target area for the following reasons: 1) The Lower Face manifests the greatest with thinning, fine wrinkling and general fragility of the skin, 2) Volumization is not always aesthetically pleasing in this area but firmness of the skin is, 3) This area is an established treatment area for MFU-V, CaHA but not with other treatment options such as Profhilo.

Tipo de estudo

Intervencional

Inscrição (Real)

13

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Singapore
      • Singapore, Singapore, Cingapura, 228210
        • Cutis Medical Laser Clinics

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

35 anos a 60 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

Inclusion Criteria:

  • Female patients with lower face wrinkles
  • Otherwise generally healthy.
  • Physically and mentally capable to provide informed consent to the study.
  • Agreement to attend all follow-up visits as scheduled

Exclusion Criteria:

  • Pregnancy or lactation;
  • History of allergic reaction to calcium hydroxylapatite injection;
  • Active local infections or skin diseases that might alter wound healing
  • Acne or keloidal scarring
  • Use of immunosuppressive drugs
  • Any other diseases which can affect the wound-healing process
  • Any procedures affecting facial wrinkles or skin quality in the lower face for the duration of the study
  • Microdermabrasion and Peels
  • Acne treatments
  • Filler and Botulinum Toxin treatments
  • Radiofrequency, Laser, IPL, Ultrasound
  • Patients that had cosmetic treatments within 3 months of the baseline visit in the treatment area
  • Subjects with dermatologic conditions in the treatment area including:
  • Acne
  • Rosacea
  • Eczema
  • Psoriasis
  • Actinic keratosis,
  • Severe sun damage
  • Scars or a history of keloids

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição sequencial
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Ultherapy and Radiesse

Delivered to the lower face areas as drawn using a single transducer with a focal depth of 1.5mm (following a previously published paper (Lowe, 2021) but with extension of the lower treatment area to the two-ruler width (Ulthera marking ruler) as treatment zones. Application will be delivered through a cross-hatching technique.

Immediately following MFU-V or up to a week after, diluted CaHA will be administered following the Global Consensus Guidelines published in 2018 by de Almeida et al as follows 1) 1 syringe or 1.5ml of CaHA diluted 1:1 with saline for a total of 3ml of solution or 1.5 diluted CaHA per side will be injected in the subdermal plane with a cannula using a retrograde fanning technique.

The Ulthera System is indicated for: - Use for noninvasive dermatological sculpting and lifting of the dermis: Upper Face, Lower Face, Neck, Décolletage.

- Non-invasive treatment of Axillary Hyperhidrosis

Radiesse injectable implant is an opaque, sterile, non-pyrogenic, semi-solid, cohesive implant. The principal component is synthetic CaHA (particle size 25-45 microns) suspended in a gel carrier of sterile water for injection, glycerin and sodium carboxymethylcellulose. In this study, one 1.5 mL syringe of Radiesse was diluted 1:1 with saline (3.0 mL total, 1.5 mL per side) and injected in the subdermal plane of the lower face with a cannula using a retrograde fanning technique, immediately after or up to one week after MFU-V.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Skin Quality
Prazo: 1 Month, 3 Months and 6 Months post intervention

Pre and post treatment comparison of change in skin quality. These will be measured using Quantificare LifeViz Micro, an established tool to objectively measure and validate treatment results of skin quality which will allow to accurately quantify changes with specific measurement tools.

1 Month, 3 Months and 6 Months post intervention
Change in Wrinkle Reduction
Prazo: 1 Month, 3 Months and 6 Months post intervention

Pre and post treatment comparison of change in dimensions of fine lines (volume/depth/length). These will be measured using Quantificare LifeViz Micro, an established tool to objectively measure and validate treatment results of lines, which will allow to accurately quantify changes with specific measurement tools.

1 Month, 3 Months and 6 Months post intervention

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Visual Aesthetic Improvement Score
Prazo: 1 Month, 3 Months and 6 Months post intervention

Pre and post treatment comparison of Visual Aesthetic Improvement Score of standardized patient photographs by study investigators. Both VISIA Imaging photographs and standard photographs will be used.

1 Month, 3 Months and 6 Months post intervention

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Patient Satisfaction
Prazo: 1 Month, 3 Months and 6 Months post intervention

To evaluate patient satisfaction of change of lower face skin quality using a 5 point scale where 1 means strongly disagree and 5 means strongly agree.

1 Month, 3 Months and 6 Months post intervention
Establish Number of Adverse Events
Prazo: 1 Month, 3 Months and 6 Months post intervention

Count the number of participants with treatment-related adverse events as assessed by CTCAE v4.0

1 Month, 3 Months and 6 Months post intervention

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de agosto de 2022

Conclusão Primária (Real)

15 de agosto de 2023

Conclusão do estudo (Real)

29 de dezembro de 2023

Datas de inscrição no estudo

Enviado pela primeira vez

3 de junho de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

19 de julho de 2022

Primeira postagem (Real)

21 de julho de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • Cutis

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

No individual participant data will be shared.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Sim

produto fabricado e exportado dos EUA

Sim

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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