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This Study Will Evaluate the Effectiveness of Juvéderm® VOLIFT™ With Lidocaine for Lip Augmentation (LIPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03796728
Recruitment Status : Active, not recruiting
First Posted : January 8, 2019
Last Update Posted : December 9, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

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

Condition or disease Intervention/treatment Phase
Lip Augmentation Device: Juvéderm® VOLIFT™ with Lidocaine Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All subjects will sign an informed consent form, and begin at the Screening Visit (V0). Filler treatment (Juvéderm® VOLIFT™ with Lidocaine) will be performed at V2 (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 (Table 1.1). Fourteen days after the initial treatment, subjects will return to the clinic and the Investigator will assess whether a Touch up treatment is to be performed at this visit (V3). Follow up visits will occur at V4 and V5 at 1, 3, and 6 months after the last treatment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: LIPS: Prospective, Open-label Study to Evaluate the Effectiveness of Juvéderm® VOLIFT™ With Lidocaine for Lip Augmentation
Actual Study Start Date : December 31, 2018
Estimated Primary Completion Date : May 26, 2020
Estimated Study Completion Date : May 26, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Juvéderm® VOLIFT™ with Lidocaine
Injectable gel that is a sterile, biodegradable, non-pyrogenic, viscoelastic, clear, colorless, homogeneous gel implant (dermal filler).
Device: Juvéderm® VOLIFT™ with Lidocaine
Injectable gel that is a sterile, biodegradable, non-pyrogenic, viscoelastic, clear, colorless, homogeneous gel implant (dermal filler).




Primary Outcome Measures :
  1. Number of patients with a one point improvement with the 5-point Lip Fullness scale (LFS2) at 30 days post last treatment [ Time Frame: 6 Months ]
    The 5-point Lip Fullness scale (LFS2) is a validated photonumeric scale that describes the fullness of the lips.


Secondary Outcome Measures :
  1. To quantify the Investigators' and subject's assessment of aesthetic improvement of the subject's lips using a Lip Fullness scale [ Time Frame: 6 Months ]
    The 5-point Lip Fullness scale (LFS2) is a validated photonumeric scale that describes the fullness of the lips.

  2. To quantify the subject's assessment of aesthetic improvement of their lips using a FACE-Q assessment [ Time Frame: 6 Months ]
    The FACE-Q is a validated 10 question assessment measuring how satisfied the subject is about their lips

  3. To quantify the Investigators' and subject's assessment of aesthetic improvement of their lips using the Global Aesthetic Improvement Scale [ Time Frame: 6 Months ]
    The Global Aesthetic Improvement Scale (GAIS) is a non-validated single question assessment of the improvement of the subject's aesthetic treatment. Both investigator and subject complete the GAIS.

  4. To quantify the subject's assessment of natural look and feel [ Time Frame: 6 Months ]
    This is a non-validated two question assessment of the natural look and feel of the aesthetic treatment on a 5-point scale.

  5. To quantify the Investigators' assessment of smoothness [ Time Frame: 6 Months ]
    This is a non-validated single question for the investigator's evaluation of the smoothness of the aesthetic treatment on a 5-point scale

  6. To quantify the Investigators' assessment of the dynamic lip lines upon animation [ Time Frame: 6 Months ]
    This is a non-validated single question for the investigator's evaluation of the improvement for the dynamic lip lines upon animation on a 5-point scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 (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)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03796728


Locations
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Portugal
Clínica Secret Beauty
Lisboa, Portugal, 1600-503
Clinica Milenio
Lisbon, Portugal, 1600-166
United Kingdom
Medical and Cosmetic Clinic
Edinburgh, United Kingdom, EH3 6RS
MediZen Ltd
Sutton Coldfield, United Kingdom, B74 2UG
Sponsors and Collaborators
Allergan
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03796728    
Other Study ID Numbers: CMO-MA-FAS-0512
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action