Status:
TERMINATED
To Evaluate the Performance and Safety of YVOIRE Y Solution 360 Versus Comparator for Lips and Perioral Area.
Lead Sponsor:
LG Chem
Conditions:
Lip Augmentation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A Study to Evaluate the Performance and Safety of YVOIRE Y-Solution 360 on Lips and Perioral Area.
Detailed Description
This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Study to Evaluate the Performance and Safety of YVOIRE Y-Solution 360 Versus Comparator for Temporary Enhancemen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2021
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT04299295
Start Date
June 5 2020
End Date
March 1 2021
Last Update
October 14 2021
Active Locations (1)
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1
Haut-und Lasercentrum Potsdam
Potsdam, Germany