Sonography-Guided Volumetric Rejuvenation on Dorsal Hands

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Ultrasound, Injection Site

Intervention / Treatment
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* Procedure: Volumetric rejuvenation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sonography-guided hand<br>One hand of the participant will be treated with sonography-guided filler injection in random | Procedure: Volumetric rejuvenation<br>* Volumetric Rejuvenation with FDA-approved fillers on the skin of the dorsal hands<br>|
| No Intervention: Blinded injected hand<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cosmetic, Volumetric rejuvenation, Filler, Dorsal hand, Ultrasound