Dorsal HandsNCT02545608
Safety and Efficacy of Restylane Vital for Skin Rejuvenation of Dorsal Hands
A study testing Restylane Vital in people with Dorsal Hands, run by Galderma R&D at 2 sites in China.
Trial summary
The purpose of this study is to determine the safety and efficacy of using Restylane Vital for skin rejuvenation of the dorsal hands. Assessment of improvement of skin structure will be done by a blinded evaluator. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dorsal Hands
- What is being tested?
- Restylane Vital
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 2 sitesChina
- Study dates
- Oct 2015to 15 Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent
- Chinese origin
- Subject willing and able to comply with the requirements of the study and agrees to adhere to the visit schedule and to be compliant to the study instructions
Who cannot join
- Any previous non-permanent implant/filler in the hands
- Any mesotherapy or resurfacing procedure in the hands within 6 months prior to baseline
- Any previous hand surgery
- Any fibrosis or scarring or deformities on the hands
- Advanced photoaged/photodamaged skin
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Randomised, Multi-centre, Evaluator-blinded, Split-hand, no Treatment-controlled Study to Evaluate the Safety and Efficacy of Restylane Vital for Skin Rejuvenation of the Dorsal Hands in Chinese Subjects
The purpose of this study is to determine the safety and efficacy of using Restylane Vital for skin rejuvenation of the dorsal hands. Assessment of improvement of skin structure will be done by a blinded evaluator.
- Conditions
- Dorsal Hands
- Being tested
- Restylane Vital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane VitalDevice
| Study group | Role | What they receive |
|---|---|---|
| Restylane Vital in both hands | Experimental | Open group used to develop a proper use of injection technique for Restylane Vital Receives: Device: Restylane Vital |
| Restylane Vital and No treatment | Other | Split-hand design: Restylane Vital in one hand and initially no treatment in the other hand Receives: Device: Restylane Vital |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Efficacy of Restylane Vital on Skin Structure Compared to no Treatment Using a Validated Scale.
Assessment of the severity of hand aging using a 5-point (ranging from 0-5) photo numeric rating scale (Hand Grading Scale), where higher scores mean a worse outcome.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionApr 2016
- Study completion15 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dorsal HandsStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Q-Med AB, Study director, Galderma R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545608
- Sponsor's protocol ID
- 43CH1406
- Status last verified
- Jun 2019
- First submitted
- 21 Aug 2015
- Last updated
- 26 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Multi-centre, Evaluator-blinded, Split-hand, no Treatment-controlled Study to Evaluate the Safety and Efficacy of Restylane Vital for Skin Rejuvenation of the Dorsal Hands in Chinese Subjects
- ClinicalTrials.gov ID
- NCT02545608
- Acronym / sponsor ID
- 43CH1406
- Conditions
- Dorsal Hands
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- 15 Mar 2017 (actual)
- First posted
- 10 Sep 2015 (estimated)
- Results
- Posted 14 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and efficacy of using Restylane Vital for skin rejuvenation of the dorsal hands. Assessment of improvement of skin structure will be done by a blinded evaluator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restylane Vital in both hands | Experimental | Device: Restylane VitalOpen group used to develop a proper use of injection technique for Restylane Vital |
| Restylane Vital and No treatment | Other | Device: Restylane VitalSplit-hand design: Restylane Vital in one hand and initially no treatment in the other hand |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed Informed Consent
- Chinese origin
- Subject willing and able to comply with the requirements of the study and agrees to adhere to the visit schedule and to be compliant to the study instructions
Key exclusion criteria (5 listed)
- Any previous non-permanent implant/filler in the hands
- Any mesotherapy or resurfacing procedure in the hands within 6 months prior to baseline
- Any previous hand surgery
- Any fibrosis or scarring or deformities on the hands
- Advanced photoaged/photodamaged skin
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 |
|---|---|---|
| Restylane Vital | Device | Restylane Vital and No treatment, Restylane Vital in both hands |
Primary outcome
The Efficacy of Restylane Vital on Skin Structure Compared to no Treatment Using a Validated Scale.
Time frame: 12 weeks
Assessment of the severity of hand aging using a 5-point (ranging from 0-5) photo numeric rating scale (Hand Grading Scale), where higher scores mean a worse outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Q-Med AB study director
Galderma R&D
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restylane Vital in people with Dorsal Hands, run by Galderma R&D at 2 sites in China.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 26 Aug 2022. 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 China. 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?
Yes. Results are posted in the registry (first posted 14 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Efficacy of Restylane Vital on Skin Structure Compared to no Treatment Using a Validated Scale. (time frame: 12 weeks). 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 26 Aug 2022.