Wrinkle Severity Rating Scale(WSRS) Grade 3 (Moderate) or 4 (Severe) of Nasolabial Folds Clinical Trial
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
| Verified date | December 2017 |
| Source | Yooyoung Pharmaceutical Co., Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 107 |
| Est. completion date | November 21, 2017 |
| Est. primary completion date | November 21, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 30 Years to 75 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Chung-Ang Univ. Medical Center | Seoul | |
| Korea, Republic of | Konkuk University Medical Center | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yooyoung Pharmaceutical Co., Ltd. |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 2, 8, 16 weeks | |
| Secondary | The change in Wrinkle Severity Rating Scale (WSRS) as evaluated by investigator. | Score of WSRS assessed by the investigator | from baseline to 2, 8, 16, 24 weeks | |
| Secondary | Proportion of subjects with a = 1 point on Global Aesthetic Improvement Scale as evaluated by an investigator | Score of GAIS assessed by the investigator | 2, 8, 16, 24 weeks after week 0 (injection date) | |
| Secondary | Proportion of subjects with a = 1 point on Global Aesthetic Improvement Scale as evaluated by a subject | Score of GAIS assessed by subject | 2, 8, 16, 24 weeks after week 0 (injection date) | |
| Secondary | Proportion of subjects with a = 1 point change on Wrinkle Severity Rating Scale as evaluated by independent evaluator through Photographs. | Score of WSRS assessed by the independent evaluator | from baseline to 2, 8, 16, 24 weeks | |
| Secondary | Proportion of subjects with a = 1 point change on Wrinkle Severity Rating Scale as evaluated by the investigator | Score of WSRS assessed by the investigator | from baseline to 2, 8, 16, 24 weeks | |
| Secondary | Visual Analogue Scale as evaluated by a subject | Score of VAS assessed by subject | week 0 (injection date) |