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

NCT05469516 | Unknown FDA Device

• 1 other identifier: Cutis
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aging

Outcome Measures

Primary Outcomes (2)

• 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.

  1 Month, 3 Months and 6 Months post intervention

• 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.

  1 Month, 3 Months and 6 Months post intervention

Secondary Outcomes (1)

• Visual Aesthetic Improvement Score

  1 Month, 3 Months and 6 Months post intervention

Other Outcomes (2)

• Patient Satisfaction

  1 Month, 3 Months and 6 Months post intervention

• Establish Number of Adverse Events

  1 Month, 3 Months and 6 Months post intervention

Study Arms (1)

Ultherapy and Radiesse

EXPERIMENTAL

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.

Device: Ulthera System [Ulthera, Inc.]; Device: Merz Radiesse Injectable Implant

Interventions

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

Ultherapy and Radiesse

Merz Radiesse Injectable Implant DEVICE

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.

Ultherapy and Radiesse

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cutis Medical Laser Clinics Pte Ltd: lead

Study Sites (1)

Cutis Medical Laser Clinics

Singapore, 228210, Singapore

Location

Related Publications (8)

• 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.

  PMID: 22316189 BACKGROUND

• 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.

  PMID: 18547187 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 34277316 RESULT

• 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.

  PMID: 34716645 RESULT

• 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.

  PMID: 30358631 RESULT

• 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.

  PMID: 31044123 RESULT

• 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.

  PMID: 25417575 RESULT

Central Study Contacts

Sylvia Ramirez, MD MPH MBA

CONTACT

+65 6801 4000; dr.sylvia@cutislaserclinics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: • Blinded assessment of aesthetic improvement at each visit as follows: Blinded reviewer to make qualitative comparisons of images of treated arms vs. baseline at each follow-up visit. If the reviewer perceived an improvement, he/she ask will be asked to select the correct post-treatment photograph
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: July 21, 2022
• Study Start: August 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: April 1, 2023
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)