Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT01176773
NCT01176773CompletedNot Applicable

Safety and Effectiveness of Juvéderm® Ultra Lip Injectable Gel for Lip Enhancement

Allergan Medical4 sites in 1 country62 target enrollmentStarted: August 2010Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
62
Locations
4
Primary Endpoint
Investigator Assessment of the Subject's Overall Lip Fullness on the 4-point Lip Fullness Scale
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to demonstrate the safety and effectiveness of Juvéderm® Ultra Lip Injectable Gel for lip enhancement.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •18 years of age or older
  • •Desire enhancement of his/her vermilion borders and/or vermilion mucosa Cupid's bow, philtral columns, perioral lines, and oral commissures may also be treated
  • •Have a baseline score of Minimal of Mild, as assessed by the Investigator according to the 4-point Lip Fullness Scale (Minimal, Mild, Moderate, Marked)
  • •Have established a realistic Lip Fullness treatment goal that Investigator agrees is achievable

Exclusion Criteria

  • •Have undergone cosmetic facial, lip or perioral procedures [e.g., face-lift or other surgeries which may alter the appearance of the lips or perioral area (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures), tissue augmentation with dermal fillers or fat injections, or mesotherapy] anywhere in the face or neck, or BOTOX® Cosmetic injections in the lower face (below the orbital rim), within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study. Note: Prior treatment with Hyaluronic Acid fillers and/or collage is allowed, provided the treatment was administered not less than 6 months prior to study entry
  • •Have ever received semi-permanent fillers or permanent facial implants (e.g., calcium hydroxylapatite, L-polylactic acid, PMMA, silicone, ePTFE) anywhere in the lips, or be planning to be implanted with any of these products at any time during the study
  • •Have a history of anaphylaxis, multiple severe allergies, atopy, allergy to local anaesthesia agents, hyaluronic acid products or Streptococcal protein, or be planning to undergo desensitization therapy during the term of the study
  • •Are pregnant, lactating, or planning to become pregnant at any time during the study
  • •Have received investigational product within 30 days prior to study enrollment or be planning to participate in another investigation during the course of this study
  • •Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
  • •Have a history of or currently suffer from autoimmune disease
  • •Have a history of treatment with interferon for chronic hepatitis C
  • •Be on an ongoing regimen of anti-coagulation therapy (e.g., warfarin) or have taken NSAIDs (e.g. aspirin, ibuprofen) or other substances known to increase coagulation time (e.g. herbal supplements with garlic or Gingko Biloba) within 10 days of undergoing study device injection. Note: Study device injection may be delayed as necessary to accommodate this 10-day wash out period

Outcomes

Primary Outcomes

Investigator Assessment of the Subject's Overall Lip Fullness on the 4-point Lip Fullness Scale

Time Frame: 3 months

The responder rate at 3 months, where a responder was defined as an improvement (increase) on the Lip Fullness Scale of ≥ 1 grade compared with the baseline assessment

Secondary Outcomes

  • Investigator Assessment of Perioral Line Severity Using the Perioral Line Severity Scale(12 months)
  • Subject Assessment of Appearance and Feel of the Lips Using the Look and Feel Scale(3 months)
  • Number of Subjects Who Attain Their Lip Treatment Goal(1-12 months)
  • Investigator Assessment of Oral Commissures Using the Oral Commissures Severity Scale(12 months)
  • Adverse Events(12 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (4)

Loading locations...

Similar Trials

Completed
Not Applicable
Safety and Effectiveness of Juvederm(R) Ultra XC Injectable Gel for Lip AugmentationLip Augmentation
NCT01197495Allergan213
Completed
Not Applicable
Safety and Effectiveness of Juvéderm® Volbella With Lidocaine Versus Restylane-L® for Lip Volume EnhancementLip Volume Enhancement
NCT01579305Allergan Medical285
Completed
Not Applicable
Safety and Efficacy of Lip Injections With Emervel Lips and Juvederm Ultra SmileLocal Tolerability After Lip Filler Injections
NCT01745250Galderma R&D40
Completed
Phase 3
JUVÉDERM® VOLUMA® With Lidocaine for Correction of Temple Hollowing in Chinese PopulationTemple Hollowing
NCT04891419Allergan168
Completed
Not Applicable
JUVÉDERM VOLUMA® to Enhance the Appearance of the Asian NoseAsian Nose Enhancement
NCT01846039Allergan29