Clinical Trial of YYD701-2 for Treatment of Nasolabial Folds

NCT ID: NCT03170050

Last Updated: 2021-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2017-11-21

Brief Summary

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.

Conditions

Wrinkle Severity Rating Scale(WSRS) Grade 3 (Moderate) or 4 (Severe) of Nasolabial Folds

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

YYD701-2

YYD701-2 Hyaluronic Acid Gel and Lidocaine Hydrochlorid, total dose 1ml, single injection

Group Type: EXPERIMENTAL

YYD701-2

Intervention Type: DEVICE

HA Filler

Restylane Perlane Lidocaine

Restylane Perlane Lidocaine Hyaluronic Acid Gel and Lidocaine Hydrochlorid, total dose 1ml, single injection

Group Type: ACTIVE_COMPARATOR

Restylane Perlane Lidocaine

Intervention Type: DEVICE

HA Filler

Interventions

YYD701-2

HA Filler

Intervention Type: DEVICE

Restylane Perlane Lidocaine

HA Filler

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yooyoung Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chung-Ang Univ. Medical Center

Seoul, , South Korea

Konkuk University Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

YYP-YYD701_001

Identifier Type: -

Identifier Source: org_study_id