Clinical trial NCT01970397: JUVEDERM® Ultra XC vs. Belotero Balance® for Perioral Lines
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Moderate to Severe Perioral Lines
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-10-28
Enrollment: 138
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With at Least a 1 Point Improvement From Baseline on the Perioral Lines Severity Scale (POLSS)
timeFrame: Baseline, Month 6
Secondary outcomes:
measure: Participant Assessed Procedural and Post-Procedural Pain Levels
timeFrame: During injection, immediately following injection, 15, 30, and 45 min post-injection
measure: Subject's Global Assessment of Change in Appearance of Perioral Lines
timeFrame: Baseline, Days 7, 14, Days 7, 14 after touch-up, Months 1, 3 and 6
Other outcomes:
Locations:
city: Chapel Hill
country: United States
state: North Carolina
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.