JUVEDERMĀ® Ultra XC vs. Belotero BalanceĀ® for Perioral Lines (NCT01970397) | Clinical Trial Compass
CompletedNot Applicable
JUVEDERMĀ® Ultra XC vs. Belotero BalanceĀ® for Perioral Lines
United States138 participantsStarted 2013-10-21
Plain-language summary
A prospective, randomized, controlled, multi-center study of the safety and effectiveness of JUVEDERMĀ® Ultra XC injectable gel versus Belotero BalanceĀ® for perioral lines
Who can participate
Age range35 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 temā¦
What they're measuring
1
Percentage of Participants With at Least a 1 Point Improvement From Baseline on the Perioral Lines Severity Scale (POLSS)