Clinical Trial of YYD701-2 for Treatment of Nasolabial Folds

Phase 3

Completed

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

• Registration Number: NCT03170050
• Lead Sponsor: Yooyoung Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-03-30
• Study First Submitted QC: 2017-05-25
• Study First Posted: 2017-05-30
• Primary Completion: 2017-11-21
• Study Completion: 2017-11-21
• Status Verified: 2017-12
• Last Update Submitted: 2021-05-07
• Last Update Posted: 2021-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Chung-Ang Univ. Medical Center; 🇰🇷 Seoul, Korea, Republic of

Konkuk University Medical Center; 🇰🇷 Seoul, Korea, Republic of