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This study will evaluate the effect of Juvederm Volift with Lidocaine, an injectable gel implant, to treat aging hands of participants 35 and older.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Juvéderm® VOLIFT with Lidocaine | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Juvéderm® VOLIFT with Lidocaine | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ALLERGAN INC. | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurofins Pharmascan /ID# 233683 | Lyon | 69100 | France |
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.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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/
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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| 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. | Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18 |
| 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. | Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18 |
| 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. | Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18 |
| 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). | Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18 |
| 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 | Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18 |
| 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 | Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18 |
| Injection Site Reactions (ISRs) evaluated by the subject 30 days after each injection using a subject injection site diary. | Day 30 |
| Number of patients experiencing one or more treatment emergent adverse events (TEAEs) | The number of patients who experienced one more TEAEs | Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18 |
| 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. | Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18 |
| 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. | Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18 |
| 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. | Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18 |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |