Trial Outcomes & Findings for Clinical Study to Evaluate the Correction of Wrinkles and Folds and Safety of YVOIRE Classic Versus Restylane in Nasolabial Fold Intradermal Injection (NCT NCT03738020)

Results Overview

Wrinkle Severity Rating Scale (WSRS) 1. Absent: no visible fold; continuous line 2. Mild: Shallow but visible fold with slight indentation; minor facial feature 3. Moderate: moderately deep fold; clear facial feature visible at normal appearance but not when stretched. Excellent correction expected. 4. Severe: very long and deep; prominent facial feature; less than 2mm visible fold when stretched 5. Extreme: extremely deep and long folds; 2-4mm visible v-shaped fold when stretched; detrimental to appearance; unlikely to have satisfactory correction with injectable implant alone

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

58 participants

Primary outcome timeframe

Week 26 (Visit 7)

Results posted on

2019-12-18

Participant Flow

spilt-face design

Participant milestones

Participant milestones
Measure	Subjects Subjects who enrolled in this study
Overall Study STARTED	58
Overall Study COMPLETED	57
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Study to Evaluate the Correction of Wrinkles and Folds and Safety of YVOIRE Classic Versus Restylane in Nasolabial Fold Intradermal Injection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HA IDF and Restylane n=58 Participants Subjects who were included in efficacy evaluation
Age, Continuous	44.40 years STANDARD_DEVIATION 5.82 • n=5 Participants
Sex: Female, Male Female	58 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment South Korea	58 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 26 (Visit 7)

Population: Spilt-face design

Wrinkle Severity Rating Scale (WSRS) 1. Absent: no visible fold; continuous line 2. Mild: Shallow but visible fold with slight indentation; minor facial feature 3. Moderate: moderately deep fold; clear facial feature visible at normal appearance but not when stretched. Excellent correction expected. 4. Severe: very long and deep; prominent facial feature; less than 2mm visible fold when stretched 5. Extreme: extremely deep and long folds; 2-4mm visible v-shaped fold when stretched; detrimental to appearance; unlikely to have satisfactory correction with injectable implant alone

Outcome measures

Outcome measures
Measure	HA IDF n=58 Participants HA IDF (YVOIRE classic): Treatment with HA IDF	Restylane n=58 Participants Restylane: Treatment with Restylane
Average of Wrinkle Severity Rating Scale (WSRS) Score Evaluated by the Evaluating Investigator at Week 26 (Visit 7) After the Final Treatment With the Investigational Medical Device	2.56 score on a scale Standard Deviation 0.68	2.56 score on a scale Standard Deviation 0.66

Adverse Events

HA IDF

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Restylane

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Systemic

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	HA IDF n=58 participants at risk Subject who were injected with investigational medical device at least once	Restylane n=58 participants at risk Subject who were injected with investigational medical device at least once	Systemic n=58 participants at risk Subject who were injected with investigational medical device at least once
Infections and infestations Nasopharyngitis	0.00% 0/58	0.00% 0/58	8.6% 5/58
General disorders Application site erythema	5.2% 3/58	5.2% 3/58	0.00% 0/58

Additional Information

Study Leader

LG Chem

Phone: 82-2-6987-4148

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER