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

NCT05469516 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-07-21

No results posted yet for this study

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

Interventions

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

DEVICE

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.

Sponsors & Collaborators

  • Cutis Medical Laser Clinics Pte Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
35 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2022-08-31
Completion
2023-04-30
FDA Device
Yes

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05469516 on ClinicalTrials.gov