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

NCT01176773 | Completed Results

• 1 other identifier: S15-002
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Lip Enhancement

Outcome Measures

Primary Outcomes (1)

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

  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

  3 months

Secondary Outcomes (5)

• Investigator Assessment of Perioral Line Severity Using the Perioral Line Severity Scale

  12 months

• Investigator Assessment of Oral Commissures Using the Oral Commissures 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

• Adverse Events

  12 months

Study Arms (1)

Juvéderm® Ultra Lip Injectable Gel

EXPERIMENTAL

Device: hyaluronic acid gel

Interventions

hyaluronic acid gel DEVICE

Dosage per Investigator's discretion to obtain lip treatment goal; 1 touch-up treatment is allowed 14 days after initial treatment. Maximum total volume per subject is 2.0 mL

Juvéderm® Ultra Lip Injectable Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan Medical: lead

Study Sites (4)

Unknown Facility

Belfast, United Kingdom

Location

Unknown Facility

Cheadle, United Kingdom

Location

Unknown Facility

Halesowen, United Kingdom

Location

Unknown Facility

Sutton Coldfield, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 23152693 BACKGROUND

Results Point of Contact

• Title: Medical Monitor
• Organization: Allergan Medical

devicetrials@allergan.com

(805) 961-5000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2010
• First Posted: August 6, 2010
• Study Start: August 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: January 1, 2012
• Last Updated: October 13, 2014
• Results First Posted: July 12, 2012

Record last verified: 2013-12

Locations

GB (4)