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

NCT03796728 | Completed Phase 4 Results

• 1 other identifier: CMO-MA-FAS-0512
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 4

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.

Conditions

Lip Augmentation

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With a ≥ 1-point Improvement (Increase) in the Lip Fullness Scale (LFS2) Compared to Baseline Assessment at Day 30

  The LFS2 is an Investigator assessment of overall lip fullness measured by a 5-point scale where: 0=Minimal (Flat or nearly flat contour; minimal red lip show), 1=Mild (Some red lip show; no lower lip pout), 2=Moderate (Moderate red lip show with slight lower lip pout), 3=Marked (Significant red lip show and lower lip pout), and 4=Very Marked (Very significant red lip show, lower lip pout, and upper lip pout). The percentage of participants with a ≥ 1-point Improvement (Increase) in the Lip Fullness Scale (LFS2) compared to Baseline are reported.

  Baseline (Prior to Treatment) to Day 30

Secondary Outcomes (8)

• Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS)

  Baseline (Prior to Treatment) to Day 30, Months 3, 6, and 12

• Change From Baseline in Participant's Assessment of Overall Satisfaction With Lips as Measured by the FACE-Q Lips Questionnaire

  Baseline (Prior to Treatment) to Day 30, Months 3, 6, and 12

• Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS)

  Day 30, Months 3, 6, and 12

• Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS

  Day 30, Months 3, 6, and 12

• Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale

  Day 30, Months 3, 6, and 12

Study Arms (1)

Juvéderm® VOLIFT™ with Lidocaine

EXPERIMENTAL

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).

Device: Juvéderm® VOLIFT™ with Lidocaine

Interventions

Juvéderm® VOLIFT™ with Lidocaine DEVICE

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

Juvéderm® VOLIFT™ with Lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (4)

Clinica Milenio

Lisbon, 1600-166, Portugal

Location

Clínica Secret Beauty

Lisbon, 1600-503, Portugal

Location

Medical and Cosmetic Clinic

Edinburgh, EH3 6RS, United Kingdom

Location

MediZen Ltd

Sutton Coldfield, B74 2UG, United Kingdom

Location

Results Point of Contact

• Title: Therapeutic Area, Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Model Details: All participants will sign an informed consent form, and begin at the Screening Visit. Filler treatment (Juvéderm® VOLIFT™ with Lidocaine) will be performed at (Initial Treatment visit) and data will be collected at this visit for all relevant parameters as per the Schedule of Study Procedures, Treatments and Assessments. Fourteen days after the initial treatment, participants will return to the clinic and the Investigator will assess whether a Touch-up treatment is to be performed at this visit. Follow up visits will occur at Day 30 and 3, 6, and 12 months after the last treatment.

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: January 8, 2019
• Study Start: December 19, 2018
• Primary Completion: June 9, 2020
• Study Completion: June 9, 2020
• Last Updated: July 28, 2021
• Results First Posted: July 28, 2021

Record last verified: 2021-07

Locations

GB (2); PT (2)