Sonography-Guided Volumetric Rejuvenation on Dorsal Hands

NCT05819450 | Unknown DMC

• 1 other identifier: 202101547B0
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Ultrasound; Injection Site

Keywords

Cosmetic; Volumetric rejuvenation; Filler; Dorsal hand; Ultrasound

Outcome Measures

Primary Outcomes (1)

• Aesthetic improvement

  5-point global aesthetic improvement scales scoring (Min:1; Max:5)

  Day 0, 30, 180 follow up

Secondary Outcomes (1)

• Thickness of the fatty laer

  Day 0, 30, 180 follow up

Study Arms (2)

Sonography-guided hand

EXPERIMENTAL

One hand of the participant will be treated with sonography-guided filler injection in random

Procedure: Volumetric rejuvenation

Blinded injected hand

NO INTERVENTION

One hand of the participant will be treated with filler injection by physician's experience without sonography-guidance in random

Interventions

Volumetric rejuvenation PROCEDURE

Volumetric Rejuvenation with FDA-approved fillers on the skin of the dorsal hands

Sonography-guided hand

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (2)

Ocean Clinic Marbella

Marbella, Spain

RECRUITING

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

Study Officials

• Yi-Teng Hung, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Teng Hung, MD

CONTACT

+886972392650; herovincent25@hotmail.com.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Fellow

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 19, 2023
• Study Start: April 15, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1); ES (1)