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

April 3, 2019 updated by: Allergan
The purpose of this study is to demonstrate the safety and effectiveness of Juvederm(R) Ultra XC Injectable Gel for lip augmentation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

213

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Juvederm(R) Ultra XC Injectable Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline, Month 3
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).
Baseline, Month 3
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.'
Baseline, Month 3
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.
Month 1, Month 3, Month 6, Month 7.5, Month 9, Month 10.5, Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2010

Primary Completion (Actual)

June 19, 2014

Study Completion (Actual)

June 15, 2015

Study Registration Dates

First Submitted

September 8, 2010

First Submitted That Met QC Criteria

September 8, 2010

First Posted (Estimate)

September 9, 2010

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 3, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JULIDO-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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