Phase 4
N=60
A Study to Evaluate the Effectiveness of Juvéderm® VOLIFT™ With Lidocaine for Lip Augmentation
Lip Augmentation
Bottom Line
View on ClinicalTrials.gov: NCT03796728 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Percentage of Participants With a ≥ 1-point Improvement (Increase) in the Lip Fullness Scale (LFS2) Compared to Baseline Assessment at Day 30 — 93.2 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Juvéderm® VOLIFT™ with Lidocaine (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a ≥ 1-point Improvement (Increase) in the Lip Fullness Scale (LFS2) Compared to Baseline Assessment at Day 30 |
93.2 | — |
| SECONDARY 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) |
0; 5; 29; 25; 0; 0 | — |
| SECONDARY Change From Baseline in Participant's Assessment of Overall Satisfaction With Lips as Measured by the FACE-Q Lips Questionnaire |
45.2; 42.7; 38.5; 23.6 | — |
| SECONDARY Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) |
32; 27; 0; 0; 0; 24 | — |
| SECONDARY Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS |
32; 25; 1; 1; 0; 28 | — |
| SECONDARY Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale |
0; 0; 3; 18; 38; 0 | — |
| SECONDARY Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale |
1; 0; 5; 21; 32; 0 | — |
| SECONDARY Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale |
0; 1; 1; 22; 35; 0 | — |
| SECONDARY Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories |
0; 2; 30; 27; 0; 2 | — |
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.
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 emp
Data sourced from ClinicalTrials.gov (NCT03796728). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.