A Clinical Study to Evaluate the Efficacy and Safety of YVOIRE Volume Plus Versus YVOIRE Volume in Nasolabial Fold Injection

• Sponsor: LG Life Sciences (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02340078
• Collaborator: (none)
• Enrollment: 62
• Arms: 2
• Duration (Months): 15

Study Details

Study Description

Brief Summary

The objective of this study was to evaluate the efficacy and safety of HA IDF II plus (with lidocaine) injected in the nasolabial fold compared to HA IDF II (without lidocaine).

Condition or Disease	Intervention/Treatment	Phase
Wrinkles	Device: HA IDF II plus; Device: HA IDF II	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: Split-face design. Subjects were decided by randomization which side of the face would be injected with the test device. According to this randomization result, the other side would be determined to be injected with a comparator. It was determined just by one randomization.Split-face design. Subjects were decided by randomization which side of the face would be injected with the test device. According to this randomization result, the other side would be determined to be injected with a comparator. It was determined just by one randomization.
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Multi Center, Double-blind, Active-controlled, Matched Pairs Design Clinical Study to Evaluate the Efficacy and Safety of HA IDF II Plus Versus HA IDF II in Nasolabial Fold Injection
• Study Start Date: Nov 1, 2013
• Actual Primary Completion Date: Feb 1, 2015
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: HA IDF II cross-linked HA filler	Device: HA IDF II
Experimental: HA IDF II plus cross-linked HA filler with lidocaine	Device: HA IDF II plus

Outcome Measures

Primary Outcome Measures

1. Proportion of the Subjects With at Least 10mm Difference in VAS Pain Scale Scores Within the Subject (VAS of the Control Device - VAS of the Test Device) Immediately After Treatment With the Investigational Devices [Visit 2 (week 0, immediately after treatment)]

   The degree of pain was evaluated by VAS (Visual Analog Scale), measuring the length from the left and to the mark by the subject in millimeter (mm) unit.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Women aged between 30 and 60

2. Those whose wrinkles in the treatment area (nasolabial fold) correspond to Stage 3 or 4 in the 5-stage Wrinkle Severity Rating Scale (WSRS) symmetrically

3. Those who were informed on the purpose, method, and effect etc. of this study and signed the informed consent form

4. Those who fell under any of the following 3 cases:

5. Surgically sterile women

6. Women in menopause over 2 years from the last menstruation, aged at least 45

7. Among the women meeting neither of a nor b, those who agreed to use at least 2 contraception methods specified below (one of the barrier methods must be included) until 14 days after the last treatment with the investigational device

• Barrier methods: Condom, diaphragm, cervical cap (pessary), spermicide

• Hormonal methods: Pills, injection (depot), skin patch, hormonal implant (Implanon), vaginal ring

• Intrauterine devices (IUDs): Cooper IUD (Loop), hormonal IUD (Mirena)

• Natural methods: Basic body temperature, ovulation period, coitus interruptus, abstinent

Exclusion Criteria:

1. Those with a skin disease (skin infection, eczema, psoriasis, rosacea, herpes etc.) in the lower 2/3 part of the face in which the wrinkle evaluation may be affected

2. Patients with a malignant tumor recognized medically important and considered as potentially affecting the clinical study

3. Women in pregnancy or lactation

4. Those with the bilirubin level exceeding 1.5 times of the upper limit of normal or the ALT/AST level exceeding 2.5 times of the upper limit of normal

5. Those with the confirmed infection of syphilis or HIV

6. Those who had an anticoagulant therapy or antiplatelet therapy within 2 weeks prior to Visit 1 (screening)

7. Those who used a topical preparation (steroid, retinoid) in the facial area within 4 weeks prior to Visit 2 (randomization )

8. Those who experienced a deep chemical peeling or a procedure judged as potentially affecting the clinical study within 3 months prior to Visit 2 (randomization)

9. Those who experienced a non-permanent filler procedure or a cosmetic surgery in the face within 9 months prior to Visit 2 (randomization)

10. Those who had an implantation procedure with a permanent substance (silicone, PAAG, PMMA, CaHA etc.) in the treatment area (nasolabial fold )

11. Those currently with a streptococcal disease

12. Those with a history of severe allergy or hypersensitivity (anaphylaxis) judged as potentially affecting the clinical study

13. Those with a history of hypertrophic scar or keloid

14. Those with a history of bleeding disorder

15. Those with a hypersensitivity to the investigational device of this clinical study or lidocaine

16. Those who refused to agree not to use a local or systemic pain-relieving agent or other pain-relieving method (e.g.: ice pack) from the midnight of the treatment day with the investigational device through the post-measurement of the last VAS pain scale

17. Those who had participated in another clinical study within 1 month prior to Visit 1 (screening)

18. Those judged by the investigator as ineligible for this clinical study

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• LG Life Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: LG Life Sciences
• ClinicalTrials.gov Identifier: NCT02340078
• Other Study ID Numbers: LG-HACL011
• First Posted: Jan 16, 2015
• Last Update Posted: Jan 23, 2019
• Last Verified: Nov 1, 2013

• Keywords provided by LG Life Sciences: the facial nasolabial fold

Study Results

Participant Flow

Recruitment Details	at 2 hospitals in korea, 62 patients. period : Nov 2013~Feb 2015
Pre-assignment Detail	spilt-face design. Subjects were decided by randomization which side of the face would be injected with the test device. According to this randomization result, the other side would be determined to be injected with a comparator. It was determined just by one randomization.

Arm/Group Title	Subject Disposition
Arm/Group Description	All Study Participants
Period Title: Overall Study
STARTED	62
COMPLETED	61
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Demographic Charateristics
Arm/Group Description	Subjects who were included in efficacy evaluation
Overall Participants	62
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.39 (7.03)
Sex/Gender, Customized (participants) [Number]
Female	62 100%
Male	0 0%

Outcome Measures

1. Primary Outcome

Title	Proportion of the Subjects With at Least 10mm Difference in VAS Pain Scale Scores Within the Subject (VAS of the Control Device - VAS of the Test Device) Immediately After Treatment With the Investigational Devices
Description	The degree of pain was evaluated by VAS (Visual Analog Scale), measuring the length from the left and to the mark by the subject in millimeter (mm) unit.
Time Frame	Visit 2 (week 0, immediately after treatment)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Subjects With at Least a 10mm Difference in VAS	Subjects With Below 10mm Difference in VAS
Arm/Group Description	Subjects with at least a 10mm difference in VAS (HA IDF II - HA IDF II plus)	Subjects with below 10mm difference in VAS (HA IDF II - HA IDF II plus)
Measure Participants	62	62
Number [participants]	59 95.2%	3 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Subjects With at Least a 10mm Difference in VAS, Subjects With Below 10mm Difference in VAS
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Subjects % with difference in VAS ≥ 10mm
	Estimated Value	0.9516
	Confidence Interval	(2-Sided) 95%; 0.87 to 0.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	Safety
Arm/Group Description	Subject who were injected with investigational medical device at least once. The 'Serious Adverse Events' and 'Other Adverse Events' described below occured in each subject regardless of the left or right of the injection site, and since all subjects were injected with both test device and comparator, it was not indicated which side the test device was injected.
All Cause Mortality
	Safety
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Safety
	Affected / at Risk (%)	# Events
Total	0/62 (0%)
Other (Not Including Serious) Adverse Events
	Safety
	Affected / at Risk (%)	# Events
Total	3/62 (4.8%)
General disorders
Administration Site Conditions	3/62 (4.8%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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