Clinical trial NCT03796728: A Study to Evaluate the Effectiveness of Juvéderm® VOLIFT™ With Lidocaine for Lip Augmentation
Official title: LIPS: A Prospective, Open-label Study to Evaluate the Effectiveness of Juvéderm® VOLIFT™ With Lidocaine for Lip Augmentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lip Augmentation
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2019-01-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Percentage of Participants With a ≥ 1-point Improvement (Increase) in the Lip Fullness Scale (LFS2) Compared to Baseline Assessment at Day 30
timeFrame: Baseline (Prior to Treatment) to Day 30
Secondary outcomes:
measure: 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)
timeFrame: Baseline (Prior to Treatment) to Day 30, Months 3, 6, and 12
measure: Change From Baseline in Participant's Assessment of Overall Satisfaction With Lips as Measured by the FACE-Q Lips Questionnaire
timeFrame: Baseline (Prior to Treatment) to Day 30, Months 3, 6, and 12
measure: Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS)
timeFrame: Day 30, Months 3, 6, and 12
measure: Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS
timeFrame: Day 30, Months 3, 6, and 12
measure: Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale
timeFrame: Day 30, Months 3, 6, and 12
measure: Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale
timeFrame: Day 30, Months 3, 6, and 12
measure: Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale
timeFrame: Day 30, Months 3, 6, and 12
measure: Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories
timeFrame: Day 30, Months 3, 6, and 12
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Clinica Milenio
city: Lisbon
country: Portugal
facility: Clínica Secret Beauty
city: Edinburgh
country: United Kingdom
facility: Medical and Cosmetic Clinic
city: Sutton Coldfield
country: United Kingdom
facility: MediZen Ltd
Study officials:
References: