VFORM: Prospective, Open Label, Study to Evaluate VOLIFT With Lidocaine Treatment for FORehead Contouring and Marionette Lines

NCT05077488 | Completed Phase 4

• 2 other identifiers: MED-MA-FAS-06512021-A00606-35
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

Brief Summary

To collect post-marketing data on Juvéderm® VOLIFT™ with Lidocaine on the following indications:

1. 1.Marionette lines (treatment skin depressions)
2. 2.Forehead contouring (face contouring)

Conditions

Marionette Lines Forehead Contouring

Keywords

skin depressions

Outcome Measures

Primary Outcomes (2)

• Forehead Contouring: Proportion of subjects with a Global Aesthetic Improvement Scale (GAIS) equal to 'improved" or "much improved" as assessed by a blinded aesthetic doctor of the contouring of the forehead using a 3D image.

  The Global Aesthetic Improvement Scale is a 5-point scale ranging from "Much Improved" to "Much Worse" and it is used for the assessment of the level of improvement to the subjects forehead contouring

  Baseline to 30 Days

• Marionette Lines: Proportion of subjects with a ≥1-point change in the Marionette Line scale from baseline before treatment to 30 days post treatment.

  The Marionette Line scale is a 5-point scale ranging from 0 (None- No Lines) to 4 (Very Severe) and it is used for the assessment of the level of improvement to the subjects marionette lines

  Baseline to 30 Days

Secondary Outcomes (12)

• Forehead Contouring: Change in overall FACE-Q Satisfaction with Facial Appearance score from baseline to 30 days, 3 months, 6 months, 9 months, 12 months

  Baseline to 30 days, 3 months, 6 months, 9 months, 12 months

• Marionette Lines: Proportion of subjects with a ≥1-point change in the Allergan Marionette Line scale from baseline before treatment to 3 months, 6 months, 9 months, 12 months

  Baseline before treatment to 3 months, 6 months, 9 months, 12 months

• Forehead Contouring: Proportion of subjects with a GAIS equal to 'improved" or "much improved" as assessed by a blinded aesthetic doctor using a 3D image at 3 months, 6 months, 9 months and 12 months

  3 months, 6 months, 9 months and 12 months

• Marionette Lines: Change in overall FACE-Q Satisfaction with Facial Appearance score from baseline to 30 days, 3 months, 6 months, 9 months, 12 months

  Baseline to 12 Months

• Forehead Contouring: Proportion of subjects with a GAIS equal to 'improved" or "much improved" as assessed by the investigator using baseline 2D photographs (live evaluation) at 30 days, 3 months, 6 months, 9 months and 12 months

  30 days to 12 Months

Study Arms (1)

Juvéderm® VOLIFT™ with Lidocaine

EXPERIMENTAL

Intradermal injection (deep dermis) in marionettes lines and/or forehead by a specialist injector

Device: Juvéderm® VOLIFT™ with Lidocaine

Interventions

Juvéderm® VOLIFT™ with Lidocaine DEVICE

Sterile gel in disposable syringe

Juvéderm® VOLIFT™ with Lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 years of age or older.
• Signed the Independent Ethics Committee (IEC)-approved informed consent form prior to any studyrelated procedures being performed.
• Eligible for treatment in at least one of the following treatment areas:
• Juvéderm VOLIFT treatment of skin depressions in the marionette lines:
• Grade 1, 2, 3 or 4 on both sides at baseline in the Allergan Marionette Line Scale
• Juvéderm VOLIFT is permitted in the oral commissures, at the discretion of the subject and investigator
• Juvéderm VOLIFT treatment for irregularities of forehead contouring as assessed by the investigator and is likely to see improvement
• Accept the obligation not to receive any other facial procedures or treatments anywhere in the face during the study that are not related to the study.
• Women of childbearing potential must have a negative urine pregnancy test before each injectable treatment and practice a reliable method of contraception throughout the study.
• Ability to follow study instructions and likely to complete all required visits and assessments, as assessed by the Investigator.
• Affiliated to a health social security system.

You may not qualify if:

• In terms of population
• Females who are pregnant, nursing, or planning a pregnancy.
• Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
• Subject in a social or sanitary establishment (socially or mentally vulnerable).
• Current enrolment in an investigational drug or device study, participation in such a study within 6 weeks before enrollment, or be planning to participate in another investigation during the course of this study.
• Is an employee (or immediate relative of an employee) of the Investigator, study staff, Allergan, or a representative of Allergan.
• In France: subject having received 4500 euros indemnities for participation in researches involving human beings in the 12 previous months, including participation in the present study.
• In terms of associated pathology
• Has a history of multiple or severe allergies, anaphylaxis, atopy, or allergy to lidocaine, HA products, or Streptococcal protein, or is planning to undergo desensitization therapy during the study.
• Has an active inflammation or infection (acne, herpes,…), cancerous or precancerous lesion, or unhealed wound.
• Subject with history of hypertrophic scarring
• Has porphyria.
• Has epilepsy.
• Has impaired cardiac conduction, severely impaired hepatic function, or severe renal dysfunction.
• History of, or currently suffering from, autoimmune disease or autoimmune deficiency or being under immunosuppressive therapy.

Sponsors & Collaborators

• Allergan: lead
• Eurofins Dermscan Pharmascan: collaborator

Study Sites (1)

Eurofins Pharmascan /ID# 243454

Lyon, 69100, France

Location

Study Officials

• ALLERGAN INC.

  Allergan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 14, 2021
• Study Start: September 15, 2021
• Primary Completion: November 8, 2022
• Study Completion: November 8, 2022
• Last Updated: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• 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/

Locations

FR (1)