Clinical Trial of YYD701-2 for Treatment of Nasolabial Folds

A Multicenter, Active-controlled, Randomized, Evaluator and Subject Blinded, Split-face, Comparative, Non-inferiority and Confirmatory Clinical Study of the Efficacy and Safety Between YYD701-2 and Restylane Perlane Lidocaine for Temporary Correction of Moderate to Severe Nasolabial Folds

A multicenter, active-controlled, randomized, evaluator and subject blinded, split-face, comparative, non-inferiority, Medical device Clinical trial.

This study is randomized, evaluator and subject blinded, split-face medical device Clinical trial. The Subjects are injected investigational device(YYD701-2 or Restylane Perlane Lidocaine) in right or left nasolabial folds.

Study Overview

• Status: Completed
• Conditions: Wrinkle Severity Rating Scale(WSRS) Grade 3 (Moderate) or 4 (Severe) of Nasolabial Folds
• Intervention / Treatment: Device: YYD701-2; Device: Restylane Perlane Lidocaine

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Konkuk University Medical Center
  • Seoul, Korea, Republic of
    • Chung-Ang Univ. Medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and Female aged between 30 and 75 years, inclusive
• Subjects who want improvement of nasolabial folds that are rated as grade 3 or 4 on Wrinkle severity rating scale(WSRS)
• Subjects who have visually symmetrical bilateral nasolabial folds
• Subjects who consent to discontinue all dermatological treatment or cure including wrinkle correction in and around infraorbital region during this trial
• Subjects who voluntarily decide to participate in this trial and provide written consent in the Informed Consent Form

Exclusion Criteria:

• Subject who have bleeding disorder in the past or present
• Other criteria as identified in the protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: YYD701-2; YYD701-2 Hyaluronic Acid Gel and Lidocaine Hydrochlorid, total dose 1ml, single injection	Device: YYD701-2; HA Filler
Active Comparator: Restylane Perlane Lidocaine; Restylane Perlane Lidocaine Hyaluronic Acid Gel and Lidocaine Hydrochlorid, total dose 1ml, single injection	Device: Restylane Perlane Lidocaine; HA Filler

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in Wrinkle Severity Rating Scale (WSRS) as evaluated by independent evaluator through Photographs.	Score of WSRS assessed by the independent evaluator	from baseline to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in Wrinkle Severity Rating Scale (WSRS) as evaluated by independent evaluator through Photographs.	Score of WSRS assessed by the independent evaluator	from baseline to 2, 8, 16 weeks
The change in Wrinkle Severity Rating Scale (WSRS) as evaluated by investigator.	Score of WSRS assessed by the investigator	from baseline to 2, 8, 16, 24 weeks
Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by an investigator	Score of GAIS assessed by the investigator	2, 8, 16, 24 weeks after week 0 (injection date)
Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by a subject	Score of GAIS assessed by subject	2, 8, 16, 24 weeks after week 0 (injection date)
Proportion of subjects with a ≥ 1 point change on Wrinkle Severity Rating Scale as evaluated by independent evaluator through Photographs.	Score of WSRS assessed by the independent evaluator	from baseline to 2, 8, 16, 24 weeks
Proportion of subjects with a ≥ 1 point change on Wrinkle Severity Rating Scale as evaluated by the investigator	Score of WSRS assessed by the investigator	from baseline to 2, 8, 16, 24 weeks
Visual Analogue Scale as evaluated by a subject	Score of VAS assessed by subject	week 0 (injection date)

Collaborators and Investigators

• Sponsor: Yooyoung Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): November 21, 2017
• Study Completion (Actual): November 21, 2017

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: May 25, 2017
• First Posted (Actual): May 30, 2017

Study Record Updates

• Last Update Posted (Actual): May 10, 2021
• Last Update Submitted That Met QC Criteria: May 7, 2021
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: YYP-YYD701_001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No