Clinical Trial of YYD701-2 for Treatment of Nasolabial Folds

• Sponsor: Yooyoung Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03170050
• Collaborator: (none)
• Enrollment: 107
• Locations: 2
• Arms: 2
• Actual Duration (Months): 8.7
• Patients Per Site: 53.5
• Patients Per Site Per Month: 6.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Wrinkle Severity Rating Scale(WSRS) Grade 3 (Moderate) or 4 (Severe) of Nasolabial Folds	Device: YYD701-2; Device: Restylane Perlane Lidocaine	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 107 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: The Subjects are injected investigational devide(YYD701-2 or Restylane Perlane Lidocaine) in right or left nasolabial foldsThe Subjects are injected investigational devide(YYD701-2 or Restylane Perlane Lidocaine) in right or left nasolabial folds
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 1, 2017
• Actual Primary Completion Date: Nov 21, 2017
• Actual Study Completion Date: Nov 21, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: YYD701-2 YYD701-2 Hyaluronic Acid Gel and Lidocaine Hydrochlorid, total dose 1ml, single injection	Device: YYD701-2; HA Filler
Active Comparator: Restylane Perlane Lidocaine Restylane Perlane Lidocaine Hyaluronic Acid Gel and Lidocaine Hydrochlorid, total dose 1ml, single injection	Device: Restylane Perlane Lidocaine; HA Filler

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. Visual Analogue Scale as evaluated by a subject [week 0 (injection date)]

   Score of VAS assessed by subject

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chung-Ang Univ. Medical Center	Seoul		Korea, Republic of
2	Konkuk University Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Yooyoung Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yooyoung Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03170050
• Other Study ID Numbers: YYP-YYD701_001
• First Posted: May 30, 2017
• Last Update Posted: May 10, 2021
• Last Verified: Dec 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lidocaine

Study Results

No Results Posted as of May 10, 2021