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

• ClinicalTrials.gov Identifier: NCT03738020
• Recruitment Status: Completed
• First Posted: November 13, 2018
• Results First Posted: December 18, 2019
• Last Update Posted: December 18, 2019
• Sponsor: LG Life Sciences
• Information provided by (Responsible Party): LG Life Sciences

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Temporary Correction of Wrinkles
• Interventions: Device: HA IDF (YVOIRE classic); Device: Restylane
• Enrollment: 58

Participant Flow

Recruitment Details
Pre-assignment Details	spilt-face design

Arm/Group Title	Subjects
Arm/Group Description	Subjects who enrolled in this study
Period Title: Overall Study
Started	58
Completed	57
Not Completed	1

Baseline Characteristics

Arm/Group Title		HA IDF and Restylane
Arm/Group Description		Subjects who were included in efficacy evaluation
Overall Number of Baseline Participants		58
Baseline Analysis Population Description		spilt-face design
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	58 participants
		44.40 (5.82)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	58 participants
	Female	58 100.0%
	Male	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
South Korea	Number Analyzed	58 participants
		58

Outcome Measures

1. Primary Outcome

Title	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
Description	Wrinkle Severity Rating Scale (WSRS); Absent: no visible fold; continuous line; Mild: Shallow but visible fold with slight indentation; minor facial feature; Moderate: moderately deep fold; clear facial feature visible at normal appearance but not when stretched. Excellent correction expected.; Severe: very long and deep; prominent facial feature; less than 2mm visible fold when stretched; 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
Time Frame	Week 26 (Visit 7)

Outcome Measure Data

Analysis Population Description

Spilt-face design

Arm/Group Title	HA IDF	Restylane
Arm/Group Description:	HA IDF (YVOIRE classic): Treatment with HA IDF	Restylane: Treatment with Restylane
Overall Number of Participants Analyzed	58	58
Mean (Standard Deviation); Unit of Measure: score on a scale
	2.56 (0.68)	2.56 (0.66)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	HA IDF	Restylane	Systemic
Arm/Group Description	Subject who were injected with investigational medical device at least once	Subject who were injected with investigational medical device at least once	Subject who were injected with investigational medical device at least once
All-Cause Mortality
	HA IDF	Restylane	Systemic
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--
Serious Adverse Events
	HA IDF	Restylane	Systemic
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/58 (0.00%)	0/58 (0.00%)	0/58 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	HA IDF	Restylane	Systemic
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	3/58 (5.17%)	3/58 (5.17%)	5/58 (8.62%)
General disorders
Application site erythema †	3/58 (5.17%)	3/58 (5.17%)	0/58 (0.00%)
Infections and infestations
Nasopharyngitis †	0/58 (0.00%)	0/58 (0.00%)	5/58 (8.62%)
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

 

Results Point of Contact

• Name/Title: Study Leader
• Organization: LG Chem
• Phone: 82-2-6987-4148
• EMail: sodam@lgchem.com

• Responsible Party: LG Life Sciences
• ClinicalTrials.gov Identifier: NCT03738020
• Other Study ID Numbers: LG-HACL008
• First Submitted: November 9, 2018
• First Posted: November 13, 2018
• Results First Submitted: November 27, 2018
• Results First Posted: December 18, 2019
• Last Update Posted: December 18, 2019