To Evaluate the Performance and Safety of YVOIRE Y Solution 360 Versus Comparator for Lips and Perioral Area.
NCT ID: NCT04299295
Last Updated: 2021-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
118 participants
INTERVENTIONAL
2020-06-05
2021-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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YVOIRE Y-Solution 360
Hyaluronic acid dermal filler
YVOIRE Y-Solution 360
Hyaluronic acid dermal filler
Juvéderm VOLBELLA
Hyaluronic acid dermal filler
Juvéderm VOLBELLA
Hyaluronic acid dermal filler
Interventions
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YVOIRE Y-Solution 360
Hyaluronic acid dermal filler
Juvéderm VOLBELLA
Hyaluronic acid dermal filler
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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LG Chem
INDUSTRY
Responsible Party
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Principal Investigators
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Tanja C. Fischer
Role: PRINCIPAL_INVESTIGATOR
Haut-und Lasercentrum Potsdam
Locations
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Haut-und Lasercentrum Potsdam
Potsdam, , Germany
Countries
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Other Identifiers
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LG-HACL023
Identifier Type: -
Identifier Source: org_study_id