Volume Deficit in the HandNCT02650921
Effectiveness and Safety of Restylane Lyft With Lidocaine in the Dorsal Hand
A study testing Restylane Lyft with Lidocaine in people with Volume Deficit in the Hand, run by Galderma R&D at 7 sites in United States.
Trial summary
This is a randomized, evaluator-blind, split hand, multi-center study of the effectiveness and safety or Restylane Lyft with Lidocaine compared to no treatment for injection in the dorsal hand to correct volume deficits. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Volume Deficit in the Hand
- What is being tested?
- Restylane Lyft with Lidocaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 7 sitesUnited States
- Study dates
- Dec 2015to Dec 2016
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects willing to comply with the requirements of the study and providing a signed written informed consent including release of copyright of hand images.
- Males or females, 22 years of age or older
- Willing and able to perform hand functionality tests .
Who cannot join
- History of allergy or hypersensitivity to injectable HA gel or to gram positive bacterial proteins.
- History of allergy or hypersensitivity to lidocaine or other amide type anesthetics.
- Previous hand surgery including sclerotherapy, or history of hand trauma.
- Advanced photo aged/ photo damaged skin or skin condition with very crinkled or fragile skin on the dorsal hands.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Study site
Boca Raton, Florida
Study site
Boulder, Colorado
Study site
Englewood, Colorado
Study site
Mount Kisco, New York
Study site
New York, New York
Study site
St Louis, Missouri
Study site
Vista, California
About this study
Official title: A Randomized, Evaluator Blinded, Split-hand Study to Evaluate the Effectiveness and Safety of Restylane Lyft With Lidocaine Compared to no Treatment for Injection in the Dorsal Hand to Correct Volume Deficit
This is a randomized, evaluator-blind, split hand, multi-center study of the effectiveness and safety or Restylane Lyft with Lidocaine compared to no treatment for injection in the dorsal hand to correct volume deficits.
- Conditions
- Volume Deficit in the Hand
- Being tested
- Restylane Lyft with Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane Lyft with LidocaineDevice
An injectable gel of Hyaluronic Acid and Lidocaine
| Study group | Role | What they receive |
|---|---|---|
| Restylane Lyft with Lidocaine | Experimental | Not described Receives: Device: Restylane Lyft with Lidocaine |
| No Intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder Rate Using Validated Hand Grading Scale
A responder is defined as a hand with at least one improvement from baseline.
Measured: 12 Weeks
Secondary outcomes (28)
Responder Rate Using Validated Hand Grading Scale
A responder is defined as a hand with at least one point improvement from baseline
Measured: 16 weeks
Responder Rate Using Validated Hand Grading Scale
A responder is defined as a hand with at least one point improvement from baseline
Measured: 20 weeks
Responder Rate Using Validated Hand Grading Scale
A responder is defined as a hand with at least one point improvement from baseline.
Measured: 24 weeks
Improvement in Hand as Evaluated by IPR
Independent Photographic Reviewer's assessment of improvement (Yes/No)
Measured: 12 weeks
Improvement in Hand as Evaluated by IPR
Independent Photographic Reviewer's assessment of improvement (Yes/No)
Measured: 16 weeks
Improvement in Hand as Evaluated by IPR
Independent Photographic Reviewer's assessment of improvement (Yes/No)
Measured: 20 weeks
Improvement in Hand as Evaluated by IPR
Independent Photographic Reviewer's assessment of improvement (Yes/No)
Measured: 24 weeks
GAIS by Treating Investigator
Global Aesthetic Improvement Scale
Measured: 12 weeks
GAIS by Treating Investigator
Global Aesthetic Improvement Scale
Measured: 16 weeks
GAIS by Treating Investigator
Global Aesthetic Improvement Scale
Measured: 20 weeks
GAIS by Treating Investigator
Global Aesthetic Improvement Scale
Measured: 24 weeks
Evaluate GAIS by Subjects
Global Aesthetic Improvement Scale
Measured: 12 weeks
Evaluate GAIS by Subjects
Global Aesthetic Improvement Scale
Measured: 16 weeks
Evaluate GAIS by Subjects
Global Aesthetic Improvement Scale
Measured: 20 weeks
Evaluate GAIS by Subject
Global Aesthetic Improvement Scale
Measured: 24 weeks
Question 1 From Subject Satisfaction Questionnaire
Question 1: I am happier with the overall appearance of my treated hand compared to my untreated hand
Measured: Week 12
Question 2 From Subject Satisfaction Questionnaire
Question 2: My treated hand appears more attractive than my untreated hand
Measured: Week 12
Question 3 From Subject Satisfaction Questionnaire
Question 3: My treated hand looks more youthful than my untreated hand
Measured: Week 12
Question 4 From Subject Satisfaction Questionnaire
Question 4: My treated hand feels softer than my untreated hand
Measured: Week 12
Question 5 From Subject Satisfaction Questionnaire
Question 5: The skin on my treated hand appears tighter than on my untreated hand
Measured: Week 12
Question 6 From Subject Satisfaction Questionnaire
Question 6: My treated hand looks less bony than my untreated hand
Measured: Week 12
Question 7 From Subject Satisfaction Questionnaire
Question 7: The veins on my treated hand are less apparent compared to my untreated hand
Measured: Week 12
Question 8 From Subject Satisfaction Questionnaire
Question 8: My treated hand appears at least 5 years younger than my untreated hand
Measured: Week 12
Question 9 From Subject Satisfaction Questionnaire
Question 9: My treated hand appears at least 10 years younger than my untreated hand
Measured: Week 12
Question 10 From Subject Satisfaction Questionnaire
Question 10: The skin on my treated hand appears hydrated
Measured: Week 12
Question 11 From Subject Satisfaction Questionnaire
Question 11: The treatment result looks natural
Measured: Week 12
Question 12 From Subject Satisfaction Questionnaire
Question 12: I would recommend this treatment to a friend
Measured: Week 12
Question 13 From Subject Satisfaction Questionnaire
Question 13: I would have another treatment to maintain these results
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionJul 2016
- Study completionDec 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Volume Deficit in the HandStudies 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
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02650921
- Sponsor's protocol ID
- 43USH1501
- Status last verified
- Nov 2018
- First submitted
- 21 Dec 2015
- Last updated
- 26 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Moradi A, Allen S, Bank D, Marmur E, Fagien S, Glaser DA, Maguire C, Cohen JL. A Prospective, Multicenter, Randomized, Evaluator-Blinded, Split-Hand Study to Evaluate the Effectiveness and Safety of Large-Gel-Particle Hyaluronic Acid with Lidocaine for the Correction of Volume Deficits in the Dorsal Hand. Plast Reconstr Surg. 2019 Oct;144(4):586e-596e. doi: 10.1097/PRS.0000000000006070.
PubMed 31568288
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 Randomized, Evaluator Blinded, Split-hand Study to Evaluate the Effectiveness and Safety of Restylane Lyft With Lidocaine Compared to no Treatment for Injection in the Dorsal Hand to Correct Volume Deficit
- ClinicalTrials.gov ID
- NCT02650921
- Acronym / sponsor ID
- 43USH1501
- Conditions
- Volume Deficit in the Hand
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 8 Jan 2016 (estimated)
- Results
- Posted 13 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, evaluator-blind, split hand, multi-center study of the effectiveness and safety or Restylane Lyft with Lidocaine compared to no treatment for injection in the dorsal hand to correct volume deficits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restylane Lyft with Lidocaine | Experimental | Device: Restylane Lyft with Lidocaine |
| No Intervention | No intervention | – |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects willing to comply with the requirements of the study and providing a signed written informed consent including release of copyright of hand images.
- Males or females, 22 years of age or older
- Willing and able to perform hand functionality tests .
Key exclusion criteria (4 listed)
- History of allergy or hypersensitivity to injectable HA gel or to gram positive bacterial proteins.
- History of allergy or hypersensitivity to lidocaine or other amide type anesthetics.
- Previous hand surgery including sclerotherapy, or history of hand trauma.
- Advanced photo aged/ photo damaged skin or skin condition with very crinkled or fragile skin on the dorsal hands.
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 Lyft with LidocaineAn injectable gel of Hyaluronic Acid and Lidocaine | Device | Restylane Lyft with Lidocaine |
Primary outcome
Responder Rate Using Validated Hand Grading Scale
Time frame: 12 Weeks
A responder is defined as a hand with at least one improvement from baseline.
28 secondary outcomes
Responder Rate Using Validated Hand Grading Scale
Time frame: 16 weeks
Responder Rate Using Validated Hand Grading Scale
Time frame: 20 weeks
Responder Rate Using Validated Hand Grading Scale
Time frame: 24 weeks
Improvement in Hand as Evaluated by IPR
Time frame: 12 weeks
Improvement in Hand as Evaluated by IPR
Time frame: 16 weeks
Improvement in Hand as Evaluated by IPR
Time frame: 20 weeks
Improvement in Hand as Evaluated by IPR
Time frame: 24 weeks
GAIS by Treating Investigator
Time frame: 12 weeks
GAIS by Treating Investigator
Time frame: 16 weeks
GAIS by Treating Investigator
Time frame: 20 weeks
GAIS by Treating Investigator
Time frame: 24 weeks
Evaluate GAIS by Subjects
Time frame: 12 weeks
Evaluate GAIS by Subjects
Time frame: 16 weeks
Evaluate GAIS by Subjects
Time frame: 20 weeks
Evaluate GAIS by Subject
Time frame: 24 weeks
Question 1 From Subject Satisfaction Questionnaire
Time frame: Week 12
Question 2 From Subject Satisfaction Questionnaire
Time frame: Week 12
Question 3 From Subject Satisfaction Questionnaire
Time frame: Week 12
Question 4 From Subject Satisfaction Questionnaire
Time frame: Week 12
Question 5 From Subject Satisfaction Questionnaire
Time frame: Week 12
Question 6 From Subject Satisfaction Questionnaire
Time frame: Week 12
Question 7 From Subject Satisfaction Questionnaire
Time frame: Week 12
Question 8 From Subject Satisfaction Questionnaire
Time frame: Week 12
Question 9 From Subject Satisfaction Questionnaire
Time frame: Week 12
Question 10 From Subject Satisfaction Questionnaire
Time frame: Week 12
Question 11 From Subject Satisfaction Questionnaire
Time frame: Week 12
Question 12 From Subject Satisfaction Questionnaire
Time frame: Week 12
Question 13 From Subject Satisfaction Questionnaire
Time frame: Week 12
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.
- Derived from this study: PubMed 31568288Moradi A, Allen S, Bank D, Marmur E, Fagien S, Glaser DA, Maguire C, Cohen JL. A Prospective, Multicenter, Randomized, Evaluator-Blinded, Split-Hand Study to Evaluate the Effectiveness and Safety of Large-Gel-Particle Hyaluronic Acid with Lidocaine for the Correction of Volume Deficits in the Dorsal Hand. Plast Reconstr Surg. 2019 Oct;144(4):586e-596e. doi: 10.1097/PRS.0000000000006070.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restylane Lyft with Lidocaine in people with Volume Deficit in the Hand, run by Galderma R&D at 7 sites in United States.
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 4 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 7 sites in United States. 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 13 Dec 2018). 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?
Responder Rate Using Validated Hand Grading 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?
On the ClinicalTrials.gov record for NCT02650921, which also lists 1 linked publication.
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.