Hand RejuvinationPhase 1NCT04162002
Restylane® Lyft Filler Injection for Hand Rejuvenation on First Impressions
A Phase 1 study testing Restylane® Lyft in people with Hand Rejuvination, run by DeNova Research at 1 site in United States.
Trial summary
The purpose of this research is to determine the effects of Restylane® Lyft Filler injection into the back of the hand on first impressions. Read more about this study
- Who is it for?
- Ages 28 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hand Rejuvination
- What is being tested?
- Restylane® Lyft
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2019to 18 Nov 2019
- Phase
- Phase 1
- 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 28 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females of ages 28 and above.
- Subjects will be required not to have had previous filler fat injections, or other cosmetic treatments to their hands within the last 12 months.
- Subjects that understand the purpose and aspects of the study, freely sign the consent and complete the required treatment and follow up visit. -
Who cannot join
- Males and females below age of 28.
- Subjects who have had previous filler, fat injections, or other cosmetic treatments to their hands within the last 12 months.
- Subjects who are pregnant or nursing.
- Subjects with a known allergy or sensitivity to any component of the study ingredients.
- Any history of bleeding disorders (iatrogenic or otherwise). This includes persons who have undergone therapy with thrombolytics, anticoagulants, or inhibitors of platelet aggregation in the preceding 3 weeks.
- Anyone taking aspirin, ibuprofen, St. John's Wort, or high doses of Vitamin E supplements in the last 3 weeks.
- Subjects with diseases, injuries, or disabilities of the hand, including those with autoimmune disease affecting the hand, hand implants, Dupuytren's contracture, history of hand tumor, vascular malformations, Raynaud's disease and patients at risk for tendon rupture.
- Subjects that do not understand the purpose and aspects of the study, do not sign the consent and do not complete the required treatment and follow up visit will also be excluded. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Restylane® Lyft Filler Injection for Hand Rejuvenation on First Impressions
The purpose of this research is to determine the effects of Restylane® Lyft Filler injection into the back of the hand on first impressions.
- Conditions
- Hand Rejuvination
- Being tested
- Restylane® Lyft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane® LyftDrug
Filler Injection
| Study group | Role | What they receive |
|---|---|---|
| Restylane® Lyft Filler Injection | Experimental | Not described Receives: Drug: Restylane® Lyft |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of Restylane® Lyft Filler injection into the dorsal hand on first impressions.
Subjects will have a picture of their hand evaluated by third party physicians on the basis of:
Social Skills Positive mood, gets along with others well, friendly 1-10 rating
Academic Performance Intelligent, highly educated, received good grades in school 1-10 rating
Dating Success Dates frequently, lacks dating anxiety 1-10 rating
Occupational Success Good worker, competent, motivated for success, suitable as potential employee 1-10 rating
Attractiveness Pleasing appearance 1-10 rating
Financial Success Has achieved financial success, member of a high social class 1-10 rating
Relationship Success Willingness to compromise, ability to maintain long term friendships 1-10 rating
Athletic Success Excels at athletic skills, plays individual and/or team sports 1-10 rating
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start10 Oct 2019
- Primary completion18 Nov 2019
- Study completion18 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand RejuvinationStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- DeNova Research
- Sponsor type
- University, hospital or other
- Collaborators
- Galderma R&D
- Responsible party
- Principal investigator, Steven H. Dayan, University of Illinois Chicago
- Investigators
- Steven Dayan, MD, Principal investigator, DeNova Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162002
- Sponsor's protocol ID
- REST- HAN-2019
- Status last verified
- Nov 2019
- First submitted
- 1 Aug 2019
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Restylane® Lyft Filler Injection for Hand Rejuvenation on First Impressions
- ClinicalTrials.gov ID
- NCT04162002
- Acronym / sponsor ID
- REST- HAN-2019
- Conditions
- Hand Rejuvination
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- DeNova ResearchUniversity, hospital or other
- Collaborators
- Galderma R&D
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 18 Nov 2019 (actual)
- Study completion
- 18 Nov 2019 (actual)
- First posted
- 13 Nov 2019 (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 purpose of this research is to determine the effects of Restylane® Lyft Filler injection into the back of the hand on first impressions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Restylane® Lyft Filler Injection | Experimental | Drug: Restylane® Lyft |
Who may qualify
- Ages
- 28 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females of ages 28 and above.
- Subjects will be required not to have had previous filler fat injections, or other cosmetic treatments to their hands within the last 12 months.
- Subjects that understand the purpose and aspects of the study, freely sign the consent and complete the required treatment and follow up visit. -
Key exclusion criteria (8 listed)
- Males and females below age of 28.
- Subjects who have had previous filler, fat injections, or other cosmetic treatments to their hands within the last 12 months.
- Subjects who are pregnant or nursing.
- Subjects with a known allergy or sensitivity to any component of the study ingredients.
- Any history of bleeding disorders (iatrogenic or otherwise). This includes persons who have undergone therapy with thrombolytics, anticoagulants, or inhibitors of platelet aggregation in the preceding 3 weeks.
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® LyftFiller Injection | Drug | Restylane® Lyft Filler Injection |
Primary outcome
The effects of Restylane® Lyft Filler injection into the dorsal hand on first impressions.
Time frame: 4 weeks
Subjects will have a picture of their hand evaluated by third party physicians on the basis of: Social Skills Positive mood, gets along with others well, friendly 1-10 rating Academic Performance Intelligent, highly educated, received good grades in school 1-10 rating Dating Success Dates frequently, lacks dating anxiety 1-10 rating Occupational Success Good worker, competent, motivated for success, suitable as potential employee 1-10 rating Attractiveness Pleasing appearance 1-10 rating Financial Success Has achieved financial success, member of a high social class 1-10 rating Relationship Success Willingness to compromise, ability to maintain long term friendships 1-10 rating Athletic Success Excels at athletic skills, plays individual and/or team sports 1-10 rating
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- 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.
Steven Dayan, MD principal investigator
DeNova Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Restylane® Lyft in people with Hand Rejuvination, run by DeNova Research at 1 site 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 8 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 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 effects of Restylane® Lyft Filler injection into the dorsal hand on first impressions. (time frame: 4 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 19 Nov 2019.