CompletedPhase 3

Clinical Trial of YYD701-2 for Treatment of Nasolabial Folds

South Korea107 participantsStarted 2017-03-01

Plain-language 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.

Who can participate

Age range30 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

The change in Wrinkle Severity Rating Scale (WSRS) as evaluated by independent evaluator through Photographs.

Timeframe: from baseline to 24 weeks

Trial details

NCT IDNCT03170050

SponsorYooyoung Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-11-21

View on ClinicalTrials.gov More Wrinkle Severity Rating Scale(WSRS) Grade 3 (Moderate) or 4 (Severe) of Nasolabial Folds trials