Sonography-Guided Volumetric Rejuvenation on Dorsal Hands

Ultrasound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05819450
• Other study ID #: 202101547B0
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Chang Gung Memorial Hospital
• Contact: Yi-Teng Hung, MD
• Phone: +886972392650
• Email: herovincent25[@]hotmail.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Injection Site
• Ultrasound

Intervention

Procedure:
• Volumetric rejuvenation
Volumetric Rejuvenation with FDA-approved fillers on the skin of the dorsal hands

Locations

Country	Name	City	State
Spain	Ocean Clinic Marbella	Marbella
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Countries where clinical trial is conducted

Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aesthetic improvement	5-point global aesthetic improvement scales scoring (Min:1; Max:5)	Day 0, 30, 180 follow up
Secondary	Thickness of the fatty laer	Thickness of the dorsal superficial lamina (DSL) and dorsal intermediate lamina (DIL)	Day 0, 30, 180 follow up