Clinical trial NCT04390581: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Skin Depressions
Skin Elasticity
Skin Laxity
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2020-05-15
Enrollment: 75
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: At least a 1-point improvement in the Allergan Hand Volume Deficit Scale (AHVDS) by hand from baseline before treatment to 3-month visit.
timeFrame: Month 3
Secondary outcomes:
measure: Improvement from baseline to each other post-treatment time points in the Allergan Hand Volume Deficit Scale (AHVDS).
timeFrame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
measure: Investigator improvement from baseline to each post-treatment time point using the Global Aesthetic Improvement Scale (GAIS) Investigator
timeFrame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
measure: Subject improvement from baseline to each post-treatment time point using the Global Aesthetic Improvement Scale (GAIS) Subject
timeFrame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
measure: Change in HAND-Q Hand Appearance Scale from baseline before treatment to each post-treatment timepoint
timeFrame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
measure: Change in skin roughness from baseline before treatment to each post-treatment timepoint using PRIMOS ® 3D Lite for skin roughness measurements
timeFrame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
measure: Change in skin moisture from baseline before treatment to each post-treatment timepoint using MoistureMeter D®
timeFrame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
measure: Change in skin elasticity from baseline before treatment to each post-treatment timepoint using Cutometer®
timeFrame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
measure: Injection Site Reactions (ISRs) evaluated by the subject 30 days after each injection using a subject injection site diary.
timeFrame: Day 30
measure: Number of patients experiencing one or more treatment emergent adverse events (TEAEs)
timeFrame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
measure: 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.
timeFrame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
measure: 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.
timeFrame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
measure: 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.
timeFrame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Other outcomes:
Locations:
city: Lyon
country: France
facility: Eurofins Pharmascan /ID# 233683
Study officials:
affiliation: Allergan
name: ALLERGAN INC.
role: STUDY_DIRECTOR
References: