Clinical Trial of YYD701-2 for Treatment of Nasolabial Folds

YooYoung Pharmaceutical

Status and phase: Completed; Phase 3

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

Treatments: Device: YYD701-2; Device: Restylane Perlane Lidocaine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03170050

YYP-YYD701_001

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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107 participants in 2 patient groups

YYD701-2

Experimental group

Description:

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

Treatment:

Device: YYD701-2

Restylane Perlane Lidocaine

Active Comparator group

Description:

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

Treatment:

Device: Restylane Perlane Lidocaine