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Safety and Effectiveness of Juvederm(R) Ultra XC Injectable Gel for Lip Augmentation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01197495
First received: September 8, 2010
Last updated: April 29, 2016
Last verified: April 2016
  Purpose
The purpose of this study is to demonstrate the safety and effectiveness of Juvederm(R) Ultra XC Injectable Gel for lip augmentation

Condition Intervention
Lip Augmentation
Device: hyaluronic acid gel

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Subjects With ≥1-Point Improvement on the Investigator Assessed 5-point Lip Fullness Scale 2 (LFS2) [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
    Overall lip fullness is assessed by the blinded Evaluating Investigator compared to baseline using the 5-point LFS2. Scores range from 1=minimal improvement to 5=very marked improvement.


Secondary Outcome Measures:
  • Percentage of Subjects With ≥1-Point Improvement on the Perioral Line (POL) Severity Scale [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
    Subject's upper lip perioral lines are assessed compared to baseline using the 4-point validated POL Severity Scale. Scores range from 0=None (best) to 3=Severe (worst).

  • Percentage of Oral Commissures With ≥1-Point Improvement on the Oral Commissures Severity (OCS) Scale [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
    Subject's right and left oral commissures are assessed compared to baseline using the validated OCS Scale. Scores range from 0=none (best) to 3=severe (worst).

  • Percentage of Subjects Achieving Their Personal Treatment Goal of Overall Lip Fullness [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
    Subjects assessed their personal treatment goal of overall lip fullness as 'achieved' or 'not achieved.'

  • Duration Effect of Treatment on Lip Fullness [ Time Frame: Month 1, Month 3, Month 6, Month 7.5, Month 9, Month 10.5, Month 12 ] [ Designated as safety issue: No ]
    Duration of treatment effect on lip fullness is assessed by the blinded Evaluating Investigator as ≥1-point Improvement from baseline in overall lip fullness of the eligible lip at each visit.


Enrollment: 213
Study Start Date: August 2010
Study Completion Date: June 2015
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Juvederm(R) Ultra XC Injectable Gel
Device: hyaluronic acid gel
Dosage per Investigator's discretion to obtain lip treatment gel; 1 touch-up treatment is allowed 14 to 30 days after initial treatment. Repeat treatment occurs at month 12. Subjects in the control group start with treatment at month 3. Maximum total volume per subject is 4.8 mL for initial and touch-up treatment combined.
Other Name: Juvederm(R) Ultra XC Injectable Gel
Experimental: Control
No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3.
Device: hyaluronic acid gel
Dosage per Investigator's discretion to obtain lip treatment gel; 1 touch-up treatment is allowed 14 to 30 days after initial treatment. Repeat treatment occurs at month 12. Subjects in the control group start with treatment at month 3. Maximum total volume per subject is 4.8 mL for initial and touch-up treatment combined.
Other Name: Juvederm(R) Ultra XC Injectable Gel

Detailed Description:
All subjects were randomized to either the treatment group, Juvederm(R) Ultra XC Injectable Gel, or to the control group (no treatment). At month 3, subjects in the control group crossed over to the treatment group.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female, 18 years of age or older
  • Desire augmentation of his/her lips
  • Have a pre-treatment score of Minimal or Mild

Exclusion Criteria:

  • Have lip tattoos, facial hair or scars that would interfere with visualization of the lips and perioral area for the effectiveness assessments
  • Have dentures or any device covering all or part of the upper palate, and/or severe malocclusion, dentofacial or maxillofacial deformities, or significant asymmetry of the lips and perioral area, as judged by the Treating Investigator
  • Have undergone oral surgery or other dental procedures (e.g., tooth extraction, orthodontia, or implantation) within 30 days prior to enrollment or be planning to undergo any of these procedures during the study
  • Have ever undergone facial plastic surgery or received semi-permanent fillers or permanent facial implants (e.g., calcium hydroxylapatite, L-polylactic acid, PMMA, silicone, ePTFE) anywhere in the face or neck, or be planning to be implanted with any of these products at any time during the study
  • Have undergone temporary dermal filler treatment within 24 months prior to study entry or be planning to undergo any of these procedures at any time during the study
  • Have undergone cosmetic facial procedures, e.g., resurfacing (laser photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel, or other ablative or non-ablative procedures) 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
  • Begin use of any new over-the-counter or prescription, oral or topical, anti-wrinkle products for the lips or around the mouth within 3 months (90 days) prior to enrollment or be planning to begin use of such products at any time during the study [NOTE: use of sunscreens and continued therapy with some cosmeceuticals (e.g., alpha hydroxy acids, glycolic acids, retinol, or retinoic acids) is allowed if the regimen was established ≥ 3months (90 days) prior to enrollment and the regimen remains unchanged during the study
  • Have a history of anaphylaxis, multiple severe allergies, atopy, allergy to lidocaine, hyaluronic acid products or Streptococcal protein, or be planning to undergo desensitization therapy during the term of the study
  • Have an active inflammation, infection, cancerous or pre-cancerous lesion, or unhealed wound in the mouth area
  • 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) within 10 days of undergoing study device injections [Study device injections may be delayed as necessary to accommodate this 10-day washout period.]
  • Be 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
  • Be an employee (or immediate relative of an employee) of the Treating Investigator, Evaluating Investigator, Sponsor or representative of the Sponsor
  • 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
  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: NCT01197495

Locations
United States, Tennessee
Nashville, Tennessee, United States
Sponsors and Collaborators
Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01197495     History of Changes
Other Study ID Numbers: JULIDO-002 
Study First Received: September 8, 2010
Results First Received: December 1, 2015
Last Updated: April 29, 2016
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on December 09, 2016