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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05469516
• Other study ID #: Cutis
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: April 2023

Study information

• Verified date: July 2022
• Source: Cutis Medical Laser Clinics Pte Ltd
• Contact: Sylvia Ramirez, MD MPH MBA
• Phone: +65 6801 4000
• Email: dr.sylvia[@]cutislaserclinics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: April 2023
• Est. primary completion date: August 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging

Intervention

Device:
• Ulthera System [Ulthera, Inc.]
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 Implant
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.

Locations

Country	Name	City	State
Singapore	Cutis Medical Laser Clinics	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Cutis Medical Laser Clinics Pte Ltd

Country where clinical trial is conducted

Singapore, 

References & Publications (8)

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. — View Citation

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. P — View Citation

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 — View Citation

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. — View Citation

Narins RS, Carruthers J, Flynn TC, Geister TL, Görtelmeyer 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. — View Citation

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. Ep — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Satisfaction	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
Other	Establish Number of Adverse Events	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
Primary	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
Primary	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	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.	1 Month, 3 Months and 6 Months post intervention