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AgingNCT05469516

Superficial MFU-V and Diluted Calcium Hydroxyapatite for the Improvement of Lower Face Skin Quality and Wrinkles

A study testing Ulthera System [Ulthera, Inc.] and Merz Radiesse Injectable Implant in people with Aging, run by Cutis Medical Laser Clinics Pte Ltd at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 35 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Aging
What is being tested?
Ulthera System [Ulthera, Inc.] and Merz Radiesse Injectable Implant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteSingapore
Study dates
1 Aug 2022to 29 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Singapore1 site
  • Cutis Medical Laser Clinics

    Singapore, Singapore, 228210

Other trials in Singapore

About this study

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.

Read the detailed description

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.

Conditions
Aging
Being tested
Ulthera System [Ulthera, Inc.], Merz Radiesse Injectable Implant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ulthera System [Ulthera, Inc.]Device

    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
  • Merz Radiesse Injectable ImplantDevice

    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.

Study groups in NCT05469516
Study groupRoleWhat they receive
Ultherapy and RadiesseExperimentalDelivered 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.
Receives: Device: Ulthera System [Ulthera, Inc.]; Device: Merz Radiesse Injectable Implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Skin Quality

    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.

    Measured: 1 Month, 3 Months and 6 Months post intervention

  2. Change in Wrinkle Reduction

    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.

    Measured: 1 Month, 3 Months and 6 Months post intervention

Secondary outcomes (1)
  1. Visual Aesthetic Improvement Score

    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.

    Measured: 1 Month, 3 Months and 6 Months post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2022
  2. Study start1 Aug 2022
  3. Primary completion15 Aug 2023
  4. Study completion29 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
This is a single centre prospective pilot study to evaluate the efficacy of combining MFU-V and diluted CaHA for improving skin quality on the lower face. Treatment protocols are as follows: 1. MFU-V 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. 2. 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.
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05469516
Sponsor's protocol ID
Cutis
Status last verified
Nov 2026
First submitted
3 Jun 2022
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: No individual participant data will be shared.

Publications

  • Narins RS, Carruthers J, Flynn TC, Geister TL, Gortelmeyer R, Hardas B, Himmrich S, Jones D, Kerscher M, de Maio M, Mohrmann C, Pooth R, Rzany B, Sattler G, Buchner L, Benter U, Breitscheidel L, Carruthers A. Validated assessment scales for the lower face. Dermatol Surg. 2012 Feb;38(2 Spec No.):333-42. doi: 10.1111/j.1524-4725.2011.02247.x.

    PubMed 22316189
  • Shoshani D, Markovitz E, Monstrey SJ, Narins DJ. The modified Fitzpatrick Wrinkle Scale: a clinical validated measurement tool for nasolabial wrinkle severity assessment. Dermatol Surg. 2008 Jun;34 Suppl 1:S85-91; discussion S91. doi: 10.1111/j.1524-4725.2008.34248.x.

    PubMed 18547187
  • Information and Instruction Manual for Cutometer® dual MPA 580. English 2019/02 DK. [Available from: https://www.courage-khazaka.de/en/16-wissenschaftliche-produkte/alle-produkte/178-cutometer-e

  • Lowe S. Single Treatment, Single Depth Superficial Microfocused Ultrasound with Visualization for Rhytid Improvement. Plast Reconstr Surg Glob Open. 2021 Jul 13;9(7):e3662. doi: 10.1097/GOX.0000000000003662. eCollection 2021 Jul.

    PubMed 34277316
  • Ramirez S, Puah IBK. Effectiveness of combined microfocused ultrasound with visualization and subdermal calcium hydroxyapatite injections for the management of brachial skin laxity. J Cosmet Dermatol. 2021 Dec;20(12):3871-3879. doi: 10.1111/jocd.14573. Epub 2021 Oct 29.

    PubMed 34716645
  • Goldie K, Peeters W, Alghoul M, Butterwick K, Casabona G, Chao YYY, Costa J, Eviatar J, Fabi SG, Lupo M, Sattler G, Waldorf H, Yutskovskaya Y, Lorenc P. Global Consensus Guidelines for the Injection of Diluted and Hyperdiluted Calcium Hydroxylapatite for Skin Tightening. Dermatol Surg. 2018 Nov;44 Suppl 1:S32-S41. doi: 10.1097/DSS.0000000000001685.

    PubMed 30358631
  • de Almeida AT, Figueredo V, da Cunha ALG, Casabona G, Costa de Faria JR, Alves EV, Sato M, Branco A, Guarnieri C, Palermo E. Consensus Recommendations for the Use of Hyperdiluted Calcium Hydroxyapatite (Radiesse) as a Face and Body Biostimulatory Agent. Plast Reconstr Surg Glob Open. 2019 Mar 14;7(3):e2160. doi: 10.1097/GOX.0000000000002160. eCollection 2019 Mar.

    PubMed 31044123
  • Casabona G, Michalany N. Microfocused ultrasound with visualization and fillers for increased neocollagenesis: clinical and histological evaluation. Dermatol Surg. 2014 Dec;40 Suppl 12:S194-8. doi: 10.1097/DSS.0000000000000231. No abstract available.

    PubMed 25417575

Questions about this trial

What is this clinical trial studying?

A study testing Ulthera System [Ulthera, Inc.] and Merz Radiesse Injectable Implant in people with Aging, run by Cutis Medical Laser Clinics Pte Ltd at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Skin Quality (time frame: 1 Month, 3 Months and 6 Months post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05469516, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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