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Oppervlakkige MFU-V en verdunde calciumhydroxyapatiet voor de verbetering van de huidkwaliteit en rimpels in het onderste deel van het gezicht

3 november 2026 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

13

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.

Studie Locaties

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

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

35 jaar tot 60 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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

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: NVT
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Skin Quality
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Visual Aesthetic Improvement Score
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Patient Satisfaction
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

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)

1 augustus 2022

Primaire voltooiing (Werkelijk)

15 augustus 2023

Studie voltooiing (Werkelijk)

29 december 2023

Studieregistratiedata

Eerst ingediend

3 juni 2022

Eerst ingediend dat voldeed aan de QC-criteria

19 juli 2022

Eerst geplaatst (Werkelijk)

21 juli 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 november 2026

Laatste update ingediend die voldeed aan QC-criteria

3 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • Cutis

Plan Individuele Deelnemersgegevens (IPD)

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

NEE

Beschrijving IPD-plan

No individual participant data will be shared.

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

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