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

NCT01970397 | Completed Results

• 1 other identifier: GMA-JUV13001
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Patients With Moderate to Severe Perioral Lines

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Participant Assessed Procedural and Post-Procedural Pain Levels

  During injection, immediately following injection, 15, 30, and 45 min post-injection

• Subject's Global Assessment of Change in Appearance of Perioral Lines

  Baseline, Days 7, 14, Days 7, 14 after touch-up, Months 1, 3 and 6

Study Arms (2)

JUVEDERM® Ultra XC

EXPERIMENTAL

Perioral lines treated with JUVEDERM® Ultra XC

Device: JUVEDERM® Ultra XC

Belotero Balance®

EXPERIMENTAL

Perioral Lines treated with Belotero Balance®

Device: Belotero Balance®

Interventions

JUVEDERM® Ultra XC DEVICE

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).

JUVEDERM® Ultra XC

Belotero Balance® DEVICE

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).

Belotero Balance®

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Chapel Hill, North Carolina, United States

Location

Related Publications (1)

• 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.

  PMID: 26606435 BACKGROUND

Results Point of Contact

• Title: Vice President Medical Affairs,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: October 28, 2013
• Study Start: October 21, 2013
• Primary Completion: August 4, 2014
• Study Completion: August 4, 2014
• Last Updated: April 16, 2019
• Results First Posted: September 2, 2015

Record last verified: 2019-04

Locations

US (1)