Sonography-Guided Volumetric Rejuvenation on Dorsal Hands

Sonography-Guided Volumetric Rejuvenation on Dorsal Hands: A Split-Hand Randomized Controlled Trial

The goal of this randomized controlled study is to guide volumetric rejuvenation on dorsal hands with the maximal aesthetic appearance. The main questions it aims to answer are:

• Which fatty layer(s) is/are the most suitable for filler injection?
• Is it feasible to make precise filler injections with sonography guidance? Participants will receive sonography-guided injection on the one hand and another with blinded injection.

Study Overview

• Status: Recruiting
• Conditions: Ultrasound; Injection Site
• Intervention / Treatment: Procedure: Volumetric rejuvenation

Detailed Description

In our previous study, volumetric fat loss was noted in the 3 fatty laminae of dorsal hands during aging; the dorsal intermediate lamina (DIL) showed the greatest progressive fat loss after the age of 30. Volumetric rejuvenation of the 3 laminae may result in the most aesthetic appearance, especially in women. It is necessary to develop precise rejuvenation therapies according to the aging process of the dorsum of the hands that will yield the most aesthetic appearance.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi-Teng Hung, MD; Phone Number: +886972392650; Email: herovincent25@hotmail.com.tw

Study Locations

• Spain
  • Marbella, Spain
    • Recruiting
    • Ocean Clinic Marbella
    • Contact: Gabriela Casabona, MD; Email: grcasabona@gmail.com
• Taiwan
  • Taoyuan, Taiwan, 333
    • Recruiting
    • Chang Gung memorial hospital
    • Contact: Yi-Teng Hung, MD; Phone Number: +886972392650; Email: herovincent25@hotmail.com.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Diagnosis of aging changes on the dorsal hands
• Aged ≥18 years

Exclusion Criteria:

• History of severe hand dermatitis
• History of rheumatic arthritis
• History of major hand trauma
• History of limb edema
• History of recent significant weight changes
• History of previous filler injection to the dorsal hands
• History of intravenous catheter insertion and hemodialysis via the forearms or hands

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sonography-guided hand; One hand of the participant will be treated with sonography-guided filler injection in random	Procedure: Volumetric rejuvenation; Volumetric Rejuvenation with FDA-approved fillers on the skin of the dorsal hands
No Intervention: Blinded injected hand; One hand of the participant will be treated with filler injection by physician's experience without sonography-guidance in random

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aesthetic improvement	5-point global aesthetic improvement scales scoring (Min:1; Max:5)	Day 0, 30, 180 follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thickness of the fatty laer	Thickness of the dorsal superficial lamina (DSL) and dorsal intermediate lamina (DIL)	Day 0, 30, 180 follow up

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Yi-Teng Hung, MD, Chang Gung memorial hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Ultrasound; Cosmetic; Filler; Dorsal hand; Volumetric rejuvenation
• Other Study ID Numbers: 202101547B0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No