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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan ( Allergan Medical )
ClinicalTrials.gov Identifier:
NCT01176773
First received: March 23, 2010
Last updated: October 6, 2014
Last verified: December 2013
  Purpose

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


Condition Intervention
Lip Enhancement
Device: hyaluronic acid gel

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Investigator Assessment of the Subject's Overall Lip Fullness on the 4-point Lip Fullness Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Investigator Assessment of Perioral Line Severity Using the Perioral Line Severity Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Score on 4-point Perioral Line Severity Scale, where 0 is none and 3 is severe. A decreased score indicates improvement.

  • Investigator Assessment of Oral Commissures Using the Oral Commissures Severity Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Score on 4-point Oral Commissures Severity Scale, where 0 is none and 3 is severe. A decreased score indicates improvement.

  • Subject Assessment of Appearance and Feel of the Lips Using the Look and Feel Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The scale consists of subcategories pertaining to how the subjects perceived aspects of their lips (e.g., softness, smoothness, etc). The outcome measure is the percentage of subjects who scored 0-3 on an 11-point scale, where a lower score on the scale indicates a positive result.

  • Number of Subjects Who Attain Their Lip Treatment Goal [ Time Frame: 1-12 months ] [ Designated as safety issue: No ]
    Prior to treatment and in consultation with the Investigator, the subject establishes a realistic lip fullness treatment goal. At follow-up, attainment is assessed as yes or no. The outcome measure is the percentage of subjects responding "yes" as to whether their pre-established lip fullness treatment goal had been attained.

  • Adverse Events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 62
Study Start Date: August 2010
Study Completion Date: January 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Juvéderm® Ultra Lip Injectable Gel Device: hyaluronic acid gel
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01176773

Locations
United Kingdom
Belfast, United Kingdom
Cheadle, United Kingdom
Halesowen, United Kingdom
Sutton Coldfield, United Kingdom
Sponsors and Collaborators
Allergan Medical
  More Information

Publications:
Responsible Party: Allergan ( Allergan Medical )
ClinicalTrials.gov Identifier: NCT01176773     History of Changes
Other Study ID Numbers: S15-002
Study First Received: March 23, 2010
Results First Received: June 7, 2012
Last Updated: October 6, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Viscosupplements

ClinicalTrials.gov processed this record on November 27, 2014