- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05469516
Superficial MFU-V and Diluted Calcium Hydroxyapatite for the Improvement of Lower Face Skin Quality and Wrinkles
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sylvia Ramirez, MD MPH MBA
- Phone Number: +65 6801 4000
- Email: dr.sylvia@cutislaserclinics.com
Study Locations
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Singapore, Singapore, 228210
- Cutis Medical Laser Clinics
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Contact:
- Dr. Sylvia Ramirez, MD, MPH, MBA
- Phone Number: +65 6801 4000
- Email: dr.sylvia@cutislaserclinics.com
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Contact:
- Gunther Scherz, MBA
- Phone Number: +65 6801 4000
- Email: gunther@cutislaserclinics.com
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Principal Investigator:
- Sylvia Ramirez, MD, MPH, MBA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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 suspended in a gel carrier that consists primarily of water (sterile water for injection, United States pharmacopeia (USP)), glycerin (USP), and sodium carboxymethylcellulose (USP).
Radiesse injectable implant (1.5mL syringe unit) has a CaHA particle size range of 25-45 microns and should be injected sub-dermally with a 27 gauge needle.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Skin Quality
Time Frame: 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.
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1 Month, 3 Months and 6 Months post intervention
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Change in Wrinkle Reduction
Time Frame: 1 Month, 3 Months and 6 Months post intervention
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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.
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1 Month, 3 Months and 6 Months post intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Aesthetic Improvement Score
Time Frame: 1 Month, 3 Months and 6 Months post intervention
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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.
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1 Month, 3 Months and 6 Months post intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Satisfaction
Time Frame: 1 Month, 3 Months and 6 Months post intervention
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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.
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1 Month, 3 Months and 6 Months post intervention
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Establish Number of Adverse Events
Time Frame: 1 Month, 3 Months and 6 Months post intervention
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Count the number of participants with treatment-related adverse events as assessed by CTCAE v4.0
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1 Month, 3 Months and 6 Months post intervention
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Collaborators and Investigators
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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. Erratum In: Dermatol Surg. 2019 Feb;45(2):327.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Cutis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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