NCT03170050

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2017

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2017

Completed
Last Updated

May 10, 2021

Status Verified

December 1, 2017

Enrollment Period

9 months

First QC Date

March 30, 2017

Last Update Submit

May 7, 2021

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

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

    from baseline to 2, 8, 16 weeks

  • The change in Wrinkle Severity Rating Scale (WSRS) as evaluated by 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

    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

    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.

    from baseline to 2, 8, 16, 24 weeks

  • +2 more secondary outcomes

Study Arms (2)

YYD701-2

EXPERIMENTAL

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

Device: YYD701-2

Restylane Perlane Lidocaine

ACTIVE COMPARATOR

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

Device: Restylane Perlane Lidocaine

Interventions

YYD701-2DEVICE

HA Filler

YYD701-2
Restylane Perlane LidocaineDEVICE

HA Filler

Restylane Perlane Lidocaine

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chung-Ang Univ. Medical Center

Seoul, South Korea

Location

Konkuk University Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The Subjects are injected investigational devide(YYD701-2 or Restylane Perlane Lidocaine) in right or left nasolabial folds
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2017

First Posted

May 30, 2017

Study Start

March 1, 2017

Primary Completion

November 21, 2017

Study Completion

November 21, 2017

Last Updated

May 10, 2021

Record last verified: 2017-12

Locations

KR(2)