Clinical trial NCT04299295: To Evaluate the Performance and Safety of YVOIRE Y Solution 360 Versus Comparator for Lips and Perioral Area.
Official title: A Study to Evaluate the Performance and Safety of YVOIRE Y-Solution 360 Versus Comparator for Temporary Enhancement and Pouting of the Lips for Lip Augmentation and Correction of Perioral Area.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lip Augmentation
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2020-03-06
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Enhancement and Pouting of the Lips for Lip Augmentation and Correction of Perioral Area

Eligibility criteria: 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

Primary outcomes:
measure: Mean change on the overall Lip Fullness Rating Scale (LFRS) from baseline to Week12.
timeFrame: 12 weeks from baseline
measure: Responder rate calculated using Lip Fullness Rating Scale (LFRS) for overall lip at Week12.
timeFrame: 12 weeks from baseline
Secondary outcomes:
measure: Mean change on Lip Fullness Rating Scale (LFRS) from baseline to Week2, 4, 12 and 24.
timeFrame: 2, 4, 12, 24 weeks from baseline
measure: Responder rate on Lip Fullness Rating Scale (LFRS) from baseline to Week2, 4, 12 and 24.
timeFrame: 2, 4, 12, 24 weeks from baseline
measure: Mean change on Vertical Perioral Lip lines Rating Scale - At rest(VPLRS) from baseline to Week2, 4, 12 and 24.
timeFrame: 2, 4, 12, 24 weeks from baseline
measure: Responder rate on Vertical Perioral Lip lines Rating Scale - At rest(VPLRS) from baseline to Week2, 4, 12 and 24.
timeFrame: 2, 4, 12, 24 weeks from baseline
measure: Global Aesthetic Improvement Scale (GAIS) evaluation by subject and investigator.
timeFrame: 2, 4, 12, 24 weeks from baseline
Other outcomes:
Locations:
city: Potsdam
country: Germany
facility: Haut-und Lasercentrum Potsdam
Study officials:
affiliation: Haut-und Lasercentrum Potsdam
name: Tanja C. Fischer
role: PRINCIPAL_INVESTIGATOR
References: