Clinical trial NCT01176773: Safety and Effectiveness of Juvéderm® Ultra Lip Injectable Gel for Lip Enhancement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lip Enhancement
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2010-08-06
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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


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

Primary outcomes:
measure: Investigator Assessment of the Subject's Overall Lip Fullness on the 4-point Lip Fullness Scale
timeFrame: 3 months
Secondary outcomes:
measure: Investigator Assessment of Perioral Line Severity Using the Perioral Line Severity Scale
timeFrame: 12 months
measure: Investigator Assessment of Oral Commissures Using the Oral Commissures Severity Scale
timeFrame: 12 months
measure: Subject Assessment of Appearance and Feel of the Lips Using the Look and Feel Scale
timeFrame: 3 months
measure: Number of Subjects Who Attain Their Lip Treatment Goal
timeFrame: 1-12 months
measure: Adverse Events
timeFrame: 12 months
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
city: Cheadle
country: United Kingdom
city: Halesowen
country: United Kingdom
city: Sutton Coldfield
country: United Kingdom
Study officials:
References:
citation: Eccleston D, Murphy DK. Juvederm((R)) Volbella in the perioral area: a 12-month prospective, multicenter, open-label study. Clin Cosmet Investig Dermatol. 2012;5:167-72. doi: 10.2147/CCID.S35800. Epub 2012 Oct 26.