Clinical Trial of YYD701-2 for Treatment of Nasolabial Folds

Yooyoung Pharmaceutical Co., Ltd.107 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

107

Conditions

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

Interventions

YYD701-2DEVICE

HA Filler

Restylane Perlane LidocaineDEVICE

HA Filler

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (2)

Chung-Ang Univ. Medical Center

Seoul, South Korea

Konkuk University Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

The change in Wrinkle Severity Rating Scale (WSRS) as evaluated by independent evaluator through Photographs.

Score of WSRS assessed by the independent evaluator

Time frame: from baseline to 24 weeks

Secondary Outcomes

The change in Wrinkle Severity Rating Scale (WSRS) as evaluated by independent evaluator through Photographs.

Score of WSRS assessed by the independent evaluator

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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