We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01197495
First Posted: September 9, 2010
Last Update Posted: June 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  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
Intervention Model: Crossover Assignment
Masking: Single (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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: September 8, 2010
First Posted: September 9, 2010
Results First Submitted: December 1, 2015
Results First Posted: June 7, 2016
Last Update Posted: June 7, 2016
Last Verified: April 2016

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