Trial Outcomes & Findings for Observational Study to Evaluate Long-term Safety and Biodegradability of YVOIRE Volume s (NCT NCT02661737)

Last Updated: 2019-03-19

Results Overview

Recruitment status

COMPLETED

Target enrollment

503 participants

Primary outcome timeframe

Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years

Results posted on

2019-03-19

Participant milestones
Measure	YVOIRE Volume s YVOIRE volume s YVOIRE volume s
Overall Study STARTED	503
Overall Study COMPLETED	469
Overall Study NOT COMPLETED	34

Withdrawal data not reported

Observational Study to Evaluate Long-term Safety and Biodegradability of YVOIRE Volume s

Baseline characteristics by cohort
Measure	YVOIRE Volume s n=469 Participants YVOIRE volume s YVOIRE volume s
Age, Continuous	40.58 years STANDARD_DEVIATION 9.61 • n=99 Participants
Sex: Female, Male Female	462 Participants n=99 Participants
Sex: Female, Male Male	7 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	469 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	0 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants

Timeframe: Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years

Outcome measures
Measure	YVOIRE Volume s n=503 Participants YVOIRE volume s YVOIRE volume s
Incidence of Device-related Adverse Events	3 Participants

Serious events: 20 serious events

Other events: 115 other events

Deaths: 0 deaths

Serious adverse events
Measure	YVOIRE Volume s n=503 participants at risk YVOIRE volume s YVOIRE volume s
Injury, poisoning and procedural complications Breast disease	0.80% 4/503 • Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years
General disorders Others	3.2% 16/503 • Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years

Other adverse events
Measure	YVOIRE Volume s n=503 participants at risk YVOIRE volume s YVOIRE volume s
Skin and subcutaneous tissue disorders Dermatitis	7.6% 38/503 • Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years
Infections and infestations Upper respiratory tract infection	15.3% 77/503 • Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years

LG Chem

Phone: 82-2-6987-4148

Restriction type: OTHER