Wrinkle Severity Rating Scale(WSRS) Grade 3 (Moderate) or 4 (Severe) of Nasolabial Folds
Conditions
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.
Interventions
DEVICEYYD701-2
HA Filler
HA Filler
Sponsors
Yooyoung Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
The Subjects are injected investigational devide(YYD701-2 or Restylane Perlane Lidocaine) in right or left nasolabial folds
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 the investigator | from baseline to 2, 8, 16, 24 weeks | Score of WSRS assessed by the investigator |
| 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 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 |
Countries
South Korea
Outcome results
None listed