To Evaluate the Performance and Safety of YVOIRE Y Solution 360 Versus Comparator for Lips and Pe… (NCT04299295) | Clinical Trial Compass
TerminatedNot Applicable
To Evaluate the Performance and Safety of YVOIRE Y Solution 360 Versus Comparator for Lips and Perioral Area.
Stopped: Due to company's internal decision.
Germany118 participantsStarted 2020-06-05
Plain-language summary
A Study to Evaluate the Performance and Safety of YVOIRE Y-Solution 360 on Lips and Perioral Area.
Who can participate
Age range18 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:
* Male or female 18 years or above age.
* 1 or 2 of the 5-point (0-4) LFRS (Lip Fullness Rating Scale).
* Agree to use proper contraception as guided in the protocol.
* Signed for Informed Consent.
Exclusion Criteria:
* have lip tattoos, piercings, facial hair, or scars that would interfere with visualization of the lips and perioral area
* who have dentures or any device covering all or part of the upper palate, and/or severe malocclusion or dentofacial or maxillofacial deformities
* have undergone oral surgery within 6 weeks
* have received permanent facial implants in the face or neck, or are planning to be implanted with any of these products
* have undergone semi-permanent filler in lower face within 24 months
* have undergone temporary dermal filler treatment in the lower face within 12 months
* Have undergone facial tissue augmentation or facial treatment with fat or botulinum injections in the lower face within 6 months
* Have undergone mesotherapy, face lift, laser, photo modulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures in face or neck within 6 months
* have used lip plumping products within 10 days
What they're measuring
1
Mean change on the overall Lip Fullness Rating Scale (LFRS) from baseline to Week12.
Timeframe: 12 weeks from baseline
2
Responder rate calculated using Lip Fullness Rating Scale (LFRS) for overall lip at Week12.