Back to resultsA Study to Evaluate the Effect of Juvederm Volift With Lidocaine on Aging Hands in Participants Age 35 and Older
Primary Purpose
Skin Depressions, Skin Elasticity, Skin Laxity
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Juvéderm® VOLIFT with Lidocaine
Sponsored by
About this trial
This is an interventional treatment trial for Skin Depressions
Eligibility Criteria
Inclusion Criteria:
- Able to provide informed consent
- Female and male subjects over 35 years of age
- Has a desire for treatment with hyaluronic acid for skin depressions on both hands
- Must qualify to receive Juvéderm® VOLIFT®™ with Lidocaine as described in the current European Union Juvéderm® VOLIFT®™ with Lidocaine Directions For Use (DFU)
- Accepts the obligation not to receive any other hand cosmetic procedures or treatments at any time during the study (hand creams are permitted)
- Agrees not to change their normal hand care regimen throughout the course of the study.
- Women of childbearing potential must have a negative urine pregnancy test result at baseline (Day 1) and practice a reliable method of contraception throughout the study.
Exclusion Criteria:
- All contraindications as described in the current European Union Juvéderm® VOLIFT®™ with Lidocaine Directions For Use (DFU), as supplied with the product.
- Receiving or planning to receive anticoagulant therapy during the course of the study, or received anticoagulant within 10 days prior to study treatment and 3 days after.
- Receiving or is planning to receive anti-inflammatory drugs (oral/injectable corticosteroids or NSAIDs, e.g., aspirin, ibuprofen), or other substances known to increase coagulation time (vitamins or herbal supplements, e.g., Vitamin E, gingko) for 10 days prior to study treatment and 3 days after
- Undergone hand surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers or be planning to undergo any of these procedures at any time during the study
- Undergone temporary hand dermal filler injections with any substance within 12 months prior to entry in the study
- Noticeable scarring, active inflammation, infection, cancerous or pre-cancerous lesion, or unhealed wound or have undergone radiation treatment in the area to be treated
- Subject with a dental infection (e.g. infected tooth or paradonitis) or have received dental cleaning within one month of such infection
- Subject with history of hypertrophic scarring on hands
- Any fibrosis or scarring or deformities on the hands - History of neurological disease that may affect peripheral neurological function
- Subjects with a history of Raynaud´s disease or phenomenon, or history of other disease that may affect peripheral circulation
- Subjects with a history of autoimmune disease or joint disease or connective tissue disease (e.g., rheumatoid arthritis, lupus, scleroderma etc.)
- Woman pregnant, lactating, or planning to become pregnant at any time during the study
- Received any investigational product within 30 days prior to study enrollment or be planning to participate in another investigation during the course of this study
- Subject with any skin disease (acute and/or chronic) on the treated zone, likely to interfere with the measured parameters or to put the subject to an undue risk.
- Subject with multiple allergies, anaphylactic shock history, evolutive allergic pathologies.
Sites / Locations
- Eurofins Pharmascan /ID# 233683
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Juvéderm® VOLIFT with Lidocaine
Arm Description
All participants to be injected with Juvéderm® VOLIFT with Lidocaine in both hands no more than 6ml total per both hands. Optional touch-up will be done on Day 30 according to aesthetic results.
Outcomes
Primary Outcome Measures
At least a 1-point improvement in the Allergan Hand Volume Deficit Scale (AHVDS) by hand from baseline before treatment to 3-month visit.
The Evaluating Investigator will grade each hand using the AHVDS 5-point scale where 0= No visible tendons and veins, 1=No protruding tendons, 2=Protruding tendons, 3=Prominent tendons, 4=Tendons very prominent.
Secondary Outcome Measures
Improvement from baseline to each other post-treatment time points in the Allergan Hand Volume Deficit Scale (AHVDS).
The Evaluating Investigator will grade each hand using the AHVDS 5-point scale where 0= No visible tendons and veins, 1=No protruding tendons, 2=Protruding tendons, 3=Prominent tendons, 4=Tendons very prominent.
Investigator improvement from baseline to each post-treatment time point using the Global Aesthetic Improvement Scale (GAIS) Investigator
The Evaluating Investigator will assess the aesthetic improvement of the hands using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.
Subject improvement from baseline to each post-treatment time point using the Global Aesthetic Improvement Scale (GAIS) Subject
The Subject will assess the aesthetic improvement of the hands using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.
Change in HAND-Q Hand Appearance Scale from baseline before treatment to each post-treatment timepoint
The Subjects will answer the HAND-Q Hand Appearance Scale questionnaire before injection (baseline) and at each time points after injection. One questionnaire will be completed globally for both hands, taking into account the worst hand.
Change in skin roughness from baseline before treatment to each post-treatment timepoint using PRIMOS ® 3D Lite for skin roughness measurements
Measurements of skin microrelief will be performed using PRIMOS ® 3D Lite (Phaseshift Rapid In vivo Measurement Of Skin).
Change in skin moisture from baseline before treatment to each post-treatment timepoint using MoistureMeter D®
MoistureMeter D® (Delfin Technologies) allows to measure water content of biological tissues
Change in skin elasticity from baseline before treatment to each post-treatment timepoint using Cutometer®
MPA 580 Cutometer® (Courage & Khazaka) is an in vivo non-invasive method to evaluate skin rheological properties: measures of biological extensibility and elasticity variations. Cutaneous skin elasticity measurement will be performed with a 6mm probe
Injection Site Reactions (ISRs) evaluated by the subject 30 days after each injection using a subject injection site diary.
Number of patients experiencing one or more treatment emergent adverse events (TEAEs)
The number of patients who experienced one more TEAEs
Change in baseline in hand function based on finger goniometer test that will be used to measure any changes in hand function at each post-treatment timepoint.
A finger goniometer measures range-of-motion (ROM) of finger joints (metacarpophalangeal and interphalangeal). To measure finger flexion and extension.
Change in baseline in hand function based on hand dynamometer test that will be used to measure any changes in hand function at each post-treatment timepoint.
A hand dynamometer measures the maximum isometric strength of the hand and forearm muscles. The preferred and non-preferred hand is assessed in an alternating sequence until 3 trials had been completed per hand.
Change in baseline in hand function based on pinch gauge test that will be used to measure any changes in hand function at each post-treatment timepoint.
A pinch gauge is a hand-held medical device that is used for measuring a patient's hand strength. After the first trial score is recorded, the test is repeated with the same instructions for the second and third trials and for the other hand. The scores of three successive trials for each hand tested is averaged.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04390581
Brief Title
A Study to Evaluate the Effect of Juvederm Volift With Lidocaine on Aging Hands in Participants Age 35 and Older
Official Title
A Prospective Study Evaluating the Effectiveness of Juvederm Volift With Lidocaine for Treatment of the Aging Hands
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 20, 2020 (Actual)
Primary Completion Date
December 6, 2022 (Actual)
Study Completion Date
December 6, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the effect of Juvederm Volift with Lidocaine, an injectable gel implant, to treat aging hands of participants 35 and older.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Depressions, Skin Elasticity, Skin Laxity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Juvéderm® VOLIFT with Lidocaine
Arm Type
Experimental
Arm Description
All participants to be injected with Juvéderm® VOLIFT with Lidocaine in both hands no more than 6ml total per both hands. Optional touch-up will be done on Day 30 according to aesthetic results.
Intervention Type
Device
Intervention Name(s)
Juvéderm® VOLIFT with Lidocaine
Intervention Description
Consists of one injection of Juvéderm® VOLIFT with Lidocaine to both hands no more than 6ml for both hands total on Day 1. Optional on Day 30.
Primary Outcome Measure Information:
Title
At least a 1-point improvement in the Allergan Hand Volume Deficit Scale (AHVDS) by hand from baseline before treatment to 3-month visit.
Description
The Evaluating Investigator will grade each hand using the AHVDS 5-point scale where 0= No visible tendons and veins, 1=No protruding tendons, 2=Protruding tendons, 3=Prominent tendons, 4=Tendons very prominent.
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Improvement from baseline to each other post-treatment time points in the Allergan Hand Volume Deficit Scale (AHVDS).
Description
The Evaluating Investigator will grade each hand using the AHVDS 5-point scale where 0= No visible tendons and veins, 1=No protruding tendons, 2=Protruding tendons, 3=Prominent tendons, 4=Tendons very prominent.
Time Frame
Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Title
Investigator improvement from baseline to each post-treatment time point using the Global Aesthetic Improvement Scale (GAIS) Investigator
Description
The Evaluating Investigator will assess the aesthetic improvement of the hands using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.
Time Frame
Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Title
Subject improvement from baseline to each post-treatment time point using the Global Aesthetic Improvement Scale (GAIS) Subject
Description
The Subject will assess the aesthetic improvement of the hands using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.
Time Frame
Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Title
Change in HAND-Q Hand Appearance Scale from baseline before treatment to each post-treatment timepoint
Description
The Subjects will answer the HAND-Q Hand Appearance Scale questionnaire before injection (baseline) and at each time points after injection. One questionnaire will be completed globally for both hands, taking into account the worst hand.
Time Frame
Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Title
Change in skin roughness from baseline before treatment to each post-treatment timepoint using PRIMOS ® 3D Lite for skin roughness measurements
Description
Measurements of skin microrelief will be performed using PRIMOS ® 3D Lite (Phaseshift Rapid In vivo Measurement Of Skin).
Time Frame
Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Title
Change in skin moisture from baseline before treatment to each post-treatment timepoint using MoistureMeter D®
Description
MoistureMeter D® (Delfin Technologies) allows to measure water content of biological tissues
Time Frame
Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Title
Change in skin elasticity from baseline before treatment to each post-treatment timepoint using Cutometer®
Description
MPA 580 Cutometer® (Courage & Khazaka) is an in vivo non-invasive method to evaluate skin rheological properties: measures of biological extensibility and elasticity variations. Cutaneous skin elasticity measurement will be performed with a 6mm probe
Time Frame
Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Title
Injection Site Reactions (ISRs) evaluated by the subject 30 days after each injection using a subject injection site diary.
Time Frame
Day 30
Title
Number of patients experiencing one or more treatment emergent adverse events (TEAEs)
Description
The number of patients who experienced one more TEAEs
Time Frame
Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Title
Change in baseline in hand function based on finger goniometer test that will be used to measure any changes in hand function at each post-treatment timepoint.
Description
A finger goniometer measures range-of-motion (ROM) of finger joints (metacarpophalangeal and interphalangeal). To measure finger flexion and extension.
Time Frame
Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Title
Change in baseline in hand function based on hand dynamometer test that will be used to measure any changes in hand function at each post-treatment timepoint.
Description
A hand dynamometer measures the maximum isometric strength of the hand and forearm muscles. The preferred and non-preferred hand is assessed in an alternating sequence until 3 trials had been completed per hand.
Time Frame
Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Title
Change in baseline in hand function based on pinch gauge test that will be used to measure any changes in hand function at each post-treatment timepoint.
Description
A pinch gauge is a hand-held medical device that is used for measuring a patient's hand strength. After the first trial score is recorded, the test is repeated with the same instructions for the second and third trials and for the other hand. The scores of three successive trials for each hand tested is averaged.
Time Frame
Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Able to provide informed consent
Female and male subjects over 35 years of age
Has a desire for treatment with hyaluronic acid for skin depressions on both hands
Must qualify to receive Juvéderm® VOLIFT®™ with Lidocaine as described in the current European Union Juvéderm® VOLIFT®™ with Lidocaine Directions For Use (DFU)
Accepts the obligation not to receive any other hand cosmetic procedures or treatments at any time during the study (hand creams are permitted)
Agrees not to change their normal hand care regimen throughout the course of the study.
Women of childbearing potential must have a negative urine pregnancy test result at baseline (Day 1) and practice a reliable method of contraception throughout the study.
Exclusion Criteria:
All contraindications as described in the current European Union Juvéderm® VOLIFT®™ with Lidocaine Directions For Use (DFU), as supplied with the product.
Receiving or planning to receive anticoagulant therapy during the course of the study, or received anticoagulant within 10 days prior to study treatment and 3 days after.
Receiving or is planning to receive anti-inflammatory drugs (oral/injectable corticosteroids or NSAIDs, e.g., aspirin, ibuprofen), or other substances known to increase coagulation time (vitamins or herbal supplements, e.g., Vitamin E, gingko) for 10 days prior to study treatment and 3 days after
Undergone hand surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers or be planning to undergo any of these procedures at any time during the study
Undergone temporary hand dermal filler injections with any substance within 12 months prior to entry in the study
Noticeable scarring, active inflammation, infection, cancerous or pre-cancerous lesion, or unhealed wound or have undergone radiation treatment in the area to be treated
Subject with a dental infection (e.g. infected tooth or paradonitis) or have received dental cleaning within one month of such infection
Subject with history of hypertrophic scarring on hands
Any fibrosis or scarring or deformities on the hands - History of neurological disease that may affect peripheral neurological function
Subjects with a history of Raynaud´s disease or phenomenon, or history of other disease that may affect peripheral circulation
Subjects with a history of autoimmune disease or joint disease or connective tissue disease (e.g., rheumatoid arthritis, lupus, scleroderma etc.)
Woman pregnant, lactating, or planning to become pregnant at any time during the study
Received any investigational product within 30 days prior to study enrollment or be planning to participate in another investigation during the course of this study
Subject with any skin disease (acute and/or chronic) on the treated zone, likely to interfere with the measured parameters or to put the subject to an undue risk.
Subject with multiple allergies, anaphylactic shock history, evolutive allergic pathologies.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ALLERGAN INC.
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Eurofins Pharmascan /ID# 233683
City
Lyon
ZIP/Postal Code
69100
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Learn more about this trial
A Study to Evaluate the Effect of Juvederm Volift With Lidocaine on Aging Hands in Participants Age 35 and Older
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