A Study to Evaluate the Effectiveness of Juvéderm® VOLIFT™ With Lidocaine for Lip Augmentation

NCT ID: NCT03796728

Last Updated: 2021-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-19
• Study Completion Date: 2020-06-09

Brief Summary

This is an open-label, multi-center, study where eligible participants will undergo treatment with Juvéderm® VOLIFT™ with Lidocaine injected into the lips for lip augmentation.

Detailed Description

This is a prospective, open-label, multi-center, interventional, medical device, post-marketing study. Each participant will act as his/her own control. Eligible participants will undergo treatment with Juvéderm® VOLIFT™ with Lidocaine injected into the lips for lip augmentation.

Conditions

Lip Augmentation

Study Design

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

Study Groups

Juvéderm® VOLIFT™ with Lidocaine

Initial treatment with Juvéderm® VOLIFT™ with Lidocaine injectable gel to augment the lips on Day 1, with an optional touch-up treatment 14 days later, if applicable. Volume was determined by the Investigator not to exceed 3.0 milliliters (mL).

Group Type: EXPERIMENTAL

Juvéderm® VOLIFT™ with Lidocaine

Intervention Type: DEVICE

Injectable gel that is a sterile, biodegradable, non-pyrogenic, viscoelastic, clear, colorless, homogeneous gel implant (dermal filler).

Interventions

Juvéderm® VOLIFT™ with Lidocaine

Injectable gel that is a sterile, biodegradable, non-pyrogenic, viscoelastic, clear, colorless, homogeneous gel implant (dermal filler).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Male or female, 18 years of age or older
• Signed the Institutional Independent Ethics Committee (IEC)-approved informed consent form prior to any study-related procedures being performed
• Accept the obligation not to receive any other facial procedures or treatments anywhere in the lower face (below the orbital rim), neck, and oral cavity at any time 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.

Exclusion Criteria

• Has lip tattoos, piercings, facial hair, or scars that would interfere with visualization of the lips and perioral area
• Has dentures or any device covering all or part of the upper palate, and/or severe malocclusion or dentofacial or maxillofacial deformities
• Has undergone oral surgery (e.g., tooth extraction, orthodontia, or implantation) within 6 weeks before enrollment or is planning to undergo any of these procedures during the study
• Has ever undergone facial plastic surgery or received permanent facial implants (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene) anywhere in the face or neck, or is planning to be implanted with any of these products during the study
• Has undergone semi-permanent dermal filler treatment (e.g., hyaluronic acid, calcium hydroxylapatite, poly-L-lactic acid) in the lower face (below the orbital rim) within 24 months before enrollment or is planning to undergo such treatment during the study
• 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 lower face (below the orbital rim) within 6 months before enrollment or is planning to undergo any of these procedures during the study
• Has used any lip plumping products within 10 days before enrollment or is planning to use such products during the study (study treatment may be delayed as necessary to accommodate this 10-day washout period)
• Has begun using any over-the-counter or prescription, oral or topical, anti-wrinkle products for the lips or around the mouth within 90 days before enrollment or is planning to begin using such products during the study (participants 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)
• Is on an ongoing regimen of anti-coagulation therapy (e.g., warfarin) or non-steroidal anti-inflammatory 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)
• Is on a concurrent regimen of lidocaine or structurally related local anesthetics (e.g., bupivacaine)
• Has a history of anaphylaxis, atopy, or allergy to lidocaine, hyaluronic acid (HA) products, or Streptococcal protein, or is planning to undergo desensitization therapy during the study
• Has an active inflammation, infection, cancerous or precancerous lesion, or unhealed wound in the mouth area
• Has porphyria
• Has epilepsy
• Has impaired cardiac conduction, severely impaired hepatic function, or severe renal dysfunction
• Has any uncontrolled disease
• Females who are pregnant, nursing, or planning a pregnancy
• Current enrollment 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, Allergan, or a representative of Allergan

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Allergan

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinica Milenio

Lisbon, , Portugal

Clínica Secret Beauty

Lisbon, , Portugal

Medical and Cosmetic Clinic

Edinburgh, , United Kingdom

MediZen Ltd

Sutton Coldfield, , United Kingdom

Countries

Portugal; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CMO-MA-FAS-0512

Identifier Type: -

Identifier Source: org_study_id