JUVEDERM® Ultra XC vs. Belotero Balance® for Perioral Lines

A Prospective, Randomized, Controlled, Multi-center Study of the Safety and Effectiveness of JUVEDERM® Ultra XC Injectable Gel Versus Belotero Balance® for Perioral Lines

A prospective, randomized, controlled, multi-center study of the safety and effectiveness of JUVEDERM® Ultra XC injectable gel versus Belotero Balance® for perioral lines

Study Overview

• Status: Completed
• Conditions: Patients With Moderate to Severe Perioral Lines
• Intervention / Treatment: Device: JUVEDERM® Ultra XC; Device: Belotero Balance®

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Have moderate to severe perioral lines as assessed by the Investigator using the 4-point POLSS (none, mild, moderate, and severe)
• Accept the obligation not to receive any other facial procedures or treatments at any time during the study that are not study related

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 perioral area, as judged by the Treating Investigator
• Have a history of skin cancer
• Is an active smoker
• Has noticeable acne scarring, active inflammation, infection, cancerous or precancerous lesion, or unhealed wound in the mouth area
• Have had an active oral herpes or cold sore within 12 months
• 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 undergone cosmetic facial or perioral area procedures [e.g., face-lift, or other surgeries which may alter the appearance of the perioral area, including tissue grafting, or tissue augmentation with silicone, fat, or other permanent fillers] or be planning to undergo any of these procedures at any time during the study
• Have undergone temporary or semi-permanent facial dermal filler injections (e.g., hyaluronic acid, calcium hydroxylapatite, L-Polylactic acid) in the lower face (below the orbital rim) within 24 months
• Have received mesotherapy, or resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel, or other ablative or non-ablative procedures) within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study other than study related procedures.
• Have begun use of any new over-the-counter or prescription, oral or topical, antiwrinkle products in the treatment area within 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 hydroxyl acids, glycolic acids, retinol, or retinoic acids) is allowed if the regimen was established ≥ 90 days prior to enrollment]
• Have had epilation (e.g. laser hair removal, electrolysis, threading, etc.) in the perioral area performed within 3 months
• Have received treatment with botulinum toxin of any serotype for any indication in the lower face [below the infraorbital rims (IORs)] within 1 year of the baseline visit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: JUVEDERM® Ultra XC; Perioral lines treated with JUVEDERM® Ultra XC	Device: JUVEDERM® Ultra XC; Up to 3.0 mLs JUVEDERM® Ultra XC injected into the mid to deep dermis (2.0 mLs for initial treatment and 1.0 mL for touch-up treatment).
EXPERIMENTAL: Belotero Balance®; Perioral Lines treated with Belotero Balance®	Device: Belotero Balance®; Up to 3.0 mLs Belotero Balance® injected into the mid to deep dermis (2.0 mLs for initial treatment and 1.0 mL for touch-up treatment).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With at Least a 1 Point Improvement From Baseline on the Perioral Lines Severity Scale (POLSS)	The investigator evaluated the severity of the participant's upper and low lip at Baseline (Pre-treatment) to Month 6 using the 4-point POLSS where None=No lines, Mild=Few, shallow lines, Moderate=Some, moderate lines or Severe=Many, deep lines or crevices. The percentage of participants with at least a 1 Point Improvement is reported.	Baseline, Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Assessed Procedural and Post-Procedural Pain Levels	The participant assessed procedural and post-procedural pain using an 11-point scale where: 0=no pain to 10=worst pain imaginable.	During injection, immediately following injection, 15, 30, and 45 min post-injection
Subject's Global Assessment of Change in Appearance of Perioral Lines	The participant evaluated the change in the appearance of their perioral lines (the lines that radiate outward from the edges of the upper and lower lips) using a 7-point scale where: 1 = Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; 7=Very much worse.	Baseline, Days 7, 14, Days 7, 14 after touch-up, Months 1, 3 and 6

Collaborators and Investigators

• Sponsor: Allergan

Publications and helpful links

General Publications

• Butterwick K, Marmur E, Narurkar V, Cox SE, Joseph JH, Sadick NS, Tedaldi R, Wheeler S, Kolodziejczyk JK, Gallagher CJ. HYC-24L Demonstrates Greater Effectiveness With Less Pain Than CPM-22.5 for Treatment of Perioral Lines in a Randomized Controlled Trial. Dermatol Surg. 2015 Dec;41(12):1351-60. doi: 10.1097/DSS.0000000000000576.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 21, 2013
• Primary Completion (ACTUAL): August 4, 2014
• Study Completion (ACTUAL): August 4, 2014

Study Registration Dates

• First Submitted: October 23, 2013
• First Submitted That Met QC Criteria: October 23, 2013
• First Posted (ESTIMATE): October 28, 2013

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: Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: GMA-JUV13001