Skip to main content
OpenTrials
Completed

NCT Number: NCT03170050

Clinical Trial of YYD701-2 for Treatment of 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Wrinkle Severity Rating Scale(WSRS) Grade 3 (Moderate) or 4 (Severe) of Nasolabial Folds Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chung-Ang Univ. Medical Center, Seoul, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

YYD701-2

Device

HA Filler

Restylane Perlane Lidocaine

Device

HA Filler

Primary outcomes

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

    Time frame: from baseline to 24 weeks

    Score of WSRS assessed by the independent evaluator

Secondary outcomes

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

    Time frame: from baseline to 2, 8, 16 weeks

    Score of WSRS assessed by the independent evaluator

  2. The change in Wrinkle Severity Rating Scale (WSRS) as evaluated by investigator.

    Time frame: from baseline to 2, 8, 16, 24 weeks

    Score of WSRS assessed by the investigator

  3. Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by an investigator

    Time frame: 2, 8, 16, 24 weeks after week 0 (injection date)

    Score of GAIS assessed by the investigator

  4. Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by a subject

    Time frame: 2, 8, 16, 24 weeks after week 0 (injection date)

    Score of GAIS assessed by subject

  5. Proportion of subjects with a ≥ 1 point change on Wrinkle Severity Rating Scale as evaluated by independent evaluator through Photographs.

    Time frame: from baseline to 2, 8, 16, 24 weeks

    Score of WSRS assessed by the independent evaluator

  6. Proportion of subjects with a ≥ 1 point change on Wrinkle Severity Rating Scale as evaluated by the investigator

    Time frame: from baseline to 2, 8, 16, 24 weeks

    Score of WSRS assessed by the investigator

  7. Visual Analogue Scale as evaluated by a subject

    Time frame: week 0 (injection date)

    Score of VAS assessed by subject

Sponsors and collaborators

Lead sponsor

Yooyoung Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 30, 2017
Registry last updated
May 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.