Clinical trial NCT03170050: Clinical Trial of YYD701-2 for Treatment of Nasolabial Folds
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Wrinkle Severity Rating Scale(WSRS) Grade 3 (Moderate) or 4 (Severe) of Nasolabial Folds
Lead sponsor: Yooyoung Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-05-30
Enrollment: 107
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The Subjects are injected investigational devide(YYD701-2 or Restylane Perlane Lidocaine) in right or left nasolabial folds
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The change in Wrinkle Severity Rating Scale (WSRS) as evaluated by independent evaluator through Photographs.
timeFrame: from baseline to 24 weeks
Secondary outcomes:
measure: The change in Wrinkle Severity Rating Scale (WSRS) as evaluated by independent evaluator through Photographs.
timeFrame: from baseline to 2, 8, 16 weeks
measure: The change in Wrinkle Severity Rating Scale (WSRS) as evaluated by investigator.
timeFrame: from baseline to 2, 8, 16, 24 weeks
measure: Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by an investigator
timeFrame: 2, 8, 16, 24 weeks after week 0 (injection date)
measure: Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by a subject
timeFrame: 2, 8, 16, 24 weeks after week 0 (injection date)
measure: Proportion of subjects with a ≥ 1 point change on Wrinkle Severity Rating Scale as evaluated by independent evaluator through Photographs.
timeFrame: from baseline to 2, 8, 16, 24 weeks
measure: Proportion of subjects with a ≥ 1 point change on Wrinkle Severity Rating Scale as evaluated by the investigator
timeFrame: from baseline to 2, 8, 16, 24 weeks
measure: Visual Analogue Scale as evaluated by a subject
timeFrame: week 0 (injection date)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang Univ. Medical Center
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
References: