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

NCT ID: NCT05077488

Last Updated: 2022-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 163 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-15
• Study Completion Date: 2022-11-08

Brief Summary

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

1. Marionette lines (treatment skin depressions)

2. Forehead contouring (face contouring)

Conditions

Marionette Lines Forehead Contouring

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Juvéderm® VOLIFT™ with Lidocaine

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

Group Type: EXPERIMENTAL

Juvéderm® VOLIFT™ with Lidocaine

Intervention Type: DEVICE

Sterile gel in disposable syringe

Interventions

Juvéderm® VOLIFT™ with Lidocaine

Sterile gel in disposable syringe

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Male or female, 18 years of age or older.

2. Signed the Independent Ethics Committee (IEC)-approved informed consent form prior to any studyrelated procedures being performed.

3. Eligible for treatment in at least one of the following treatment areas:

1. 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

2. Juvéderm VOLIFT treatment for irregularities of forehead contouring as assessed by the investigator and is likely to see improvement

4. 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.

5. 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.

6. Ability to follow study instructions and likely to complete all required visits and assessments, as assessed by the Investigator.

7. Affiliated to a health social security system.

Exclusion Criteria

In terms of population

1. Females who are pregnant, nursing, or planning a pregnancy.

2. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.

3. Subject in a social or sanitary establishment (socially or mentally vulnerable).

4. 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.

5. Is an employee (or immediate relative of an employee) of the Investigator, study staff, Allergan, or a representative of Allergan.

6. 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

7. 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.

8. Has an active inflammation or infection (acne, herpes,…), cancerous or precancerous lesion, or unhealed wound.

9. Subject with history of hypertrophic scarring

10. Has porphyria.

11. Has epilepsy.

12. Has impaired cardiac conduction, severely impaired hepatic function, or severe renal dysfunction.

13. History of, or currently suffering from, autoimmune disease or autoimmune deficiency or being under immunosuppressive therapy.

14. History of streptococcal disease (recurrent sore throats, acute rheumatic fever).

15. Has any uncontrolled disease.

16. Has any condition or is in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study. Relating to previous or ongoing treatment

17. Has ever undergone facial plastic surgery or received permanent facial implants (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene, threads) anywhere in the face, or is planning to be implanted with any of these products during the study.

18. Has undergone semi-permanent dermal filler treatment (e.g., hyaluronic acid, calcium hydroxyapatite, poly-L-lactic acid) in the face within 12 months before enrolment or is planning to undergo such treatment during the study.

19. Has undergone mesotherapy or cosmetic resurfacing (laser, photo-modulation, intense pulsed light, radiofrequency, dermabrasion, chemical peel, or other ablative or non-ablative procedures) anywhere in the face or neck, or Botulinum toxin injections in the face within 6 months before enrolment or is planning to undergo any of these procedures during the study.

20. Has begun using any over-the-counter or prescription, oral or topical, anti-wrinkle products within 90 days before enrolment or is planning to begin using such products during the study (subjects who have been on a regimen of such products for at least 90 days are eligible for the study if they intend to continue their regimen throughout the study).

21. Is on an ongoing regimen of anti-coagulation therapy (e.g., warfarin) or non-steroidal antiinflammatory drugs (NSAIDs) (e.g., aspirin, ibuprofen) or other substances known to increase coagulation time (e.g., herbal supplements with garlic or gingko) within 10 days of undergoing study device treatment (study treatment may be delayed as necessary to accommodate this 10- day washout period).

22. Is on a concurrent regimen of lidocaine or structurally related local anaesthetics (e.g., bupivacaine).

23. Is on an ongoing treatment that reduce or inhibit hepatic metabolism (cimetidine, beta-blockers, etc.).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eurofins Dermscan Pharmascan

INDUSTRY

Sponsor Role: collaborator

Allergan

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ALLERGAN INC.

Role: STUDY_DIRECTOR

Allergan

Locations

Eurofins Pharmascan /ID# 243454

Lyon, , France

Countries

France

Other Identifiers

2021-A00606-35

Identifier Type: OTHER

Identifier Source: secondary_id

MED-MA-FAS-0651

Identifier Type: -

Identifier Source: org_study_id