Sonography-Guided Volumetric Rejuvenation on Dorsal Hands

NCT ID: NCT05819450

Last Updated: 2023-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-15

Study Completion Date

2024-12-31

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.

Conditions

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Ultrasound Injection Site

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Sonography-guided hand

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

Group Type EXPERIMENTAL

Volumetric rejuvenation

Intervention Type PROCEDURE

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

Blinded injected hand

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Volumetric rejuvenation

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

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yi-Teng Hung

Consultant Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yi-Teng Hung, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

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Ocean Clinic Marbella

Marbella, , Spain

Site Status RECRUITING

Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status RECRUITING

Countries

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Spain Taiwan

Central Contacts

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Yi-Teng Hung, MD

Role: CONTACT

+886972392650

Facility Contacts

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Gabriela Casabona, MD

Role: primary

Yi-Teng Hung, MD

Role: primary

+886972392650

Other Identifiers

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202101547B0

Identifier Type: -

Identifier Source: org_study_id

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