UltrasoundNCT05819450
Sonography-Guided Volumetric Rejuvenation on Dorsal Hands
A study testing Volumetric rejuvenation in people with Ultrasound and Injection Site, run by Chang Gung Memorial Hospital at 2 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ultrasound, Injection Site
- What is being tested?
- Volumetric rejuvenation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Apr 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of aging changes on the dorsal hands
- Aged ≥18 years
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Spain1 site, 1 recruiting
- Recruiting
Ocean Clinic Marbella
Marbella
Gabriela Casabona, MD, grcasabona@gmail.com
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan, 333
Yi-Teng Hung, MD, +886972392650, herovincent25@hotmail.com.tw
About this study
Official title: 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.
Read the 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.
- Conditions
- Ultrasound, Injection Site
- Being tested
- Volumetric rejuvenation
- Keywords
- Cosmetic, Volumetric rejuvenation, Filler, Dorsal hand, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volumetric rejuvenationProcedure or surgery
Volumetric Rejuvenation with FDA-approved fillers on the skin of the dorsal hands
| Study group | Role | What they receive |
|---|---|---|
| Sonography-guided hand | Experimental | One hand of the participant will be treated with sonography-guided filler injection in random Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aesthetic improvement
5-point global aesthetic improvement scales scoring (Min:1; Max:5)
Measured: Day 0, 30, 180 follow up
Secondary outcomes (1)
Thickness of the fatty laer
Thickness of the dorsal superficial lamina (DSL) and dorsal intermediate lamina (DIL)
Measured: Day 0, 30, 180 follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start15 Apr 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Teng Hung, Chang Gung Memorial Hospital
- Investigators
- Yi-Teng Hung, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819450
- Sponsor's protocol ID
- 202101547B0
- Status last verified
- Aug 2023
- First submitted
- 6 Apr 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonography-Guided Volumetric Rejuvenation on Dorsal Hands: A Split-Hand Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05819450
- Acronym / sponsor ID
- 202101547B0
- Conditions
- Ultrasound, Injection Site
- Keywords
- Cosmetic, Volumetric rejuvenation, Filler, Dorsal hand, Ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sonography-guided hand | Experimental | Procedure: Volumetric rejuvenationOne hand of the participant will be treated with sonography-guided filler injection in random |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of aging changes on the dorsal hands
- Aged ≥18 years
Key exclusion criteria (7 listed)
- History of severe hand dermatitis
- History of rheumatic arthritis
- History of major hand trauma
- History of limb edema
- History of recent significant weight changes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volumetric rejuvenationVolumetric Rejuvenation with FDA-approved fillers on the skin of the dorsal hands | Procedure or surgery | Sonography-guided hand |
Primary outcome
Aesthetic improvement
Time frame: Day 0, 30, 180 follow up
5-point global aesthetic improvement scales scoring (Min:1; Max:5)
1 secondary outcome
Thickness of the fatty laer
Time frame: Day 0, 30, 180 follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-Teng Hung, MD principal investigator
Chang Gung Memorial Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volumetric rejuvenation in people with Ultrasound and Injection Site, run by Chang Gung Memorial Hospital at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi-Teng Hung, MD (+886972392650, herovincent25@hotmail.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aesthetic improvement (time frame: Day 0, 30, 180 follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.