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Overfladisk MFU-V og fortynnet kalsiumhydroksyapatitt for forbedring av lavere ansiktshudkvalitet og rynker

3. november 2026 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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

Intervensjonell

Registrering (Faktiske)

13

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

35 år til 60 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Skin Quality
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Visual Aesthetic Improvement Score
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Patient Satisfaction
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. august 2022

Primær fullføring (Faktiske)

15. august 2023

Studiet fullført (Faktiske)

29. desember 2023

Datoer for studieregistrering

Først innsendt

3. juni 2022

Først innsendt som oppfylte QC-kriteriene

19. juli 2022

Først lagt ut (Faktiske)

21. juli 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • Cutis

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

No individual participant data will be shared.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Ja

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