Safety and Effectiveness of Juvéderm® Ultra Lip Injectable Gel for Lip Enhancement | NCT01176773 | Trialant
CompletedInterventionalNot ApplicableUpdated Oct 13, 2014
Safety and Effectiveness of Juvéderm® Ultra Lip Injectable Gel for Lip Enhancement
ClinicalTrials.gov ID
NCT01176773
Lead Sponsor
Allergan MedicalINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
62Actual
Last Update Posted
Oct 13, 2014Estimated
Start Date
Aug 2010
Primary Completion Date
May 2011Actual
Completion Date
Jan 2012Actual
Brief Summary
The purpose of this study is to demonstrate the safety and effectiveness of Juvéderm® Ultra Lip Injectable Gel for lip enhancement.
Lip Enhancement
hyaluronic acid gel
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Eligibility Criteria
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