A Clinical Study to Evaluate the Efficacy and Safety of the Injection With UNIVELO Sub-Q, as Compared to Restylane® Sub-Q, in the Temporary Correction of the Nasolabial Fold

Jetema Co., Ltd.

Status

Completed

Conditions

Nasolabial Fold

Treatments

Device: Restylane Sub-Q 2mL

Device: UNIVELO Sub-Q 2mL

Study type

Interventional

Funder types

Industry

Identifiers

PRO_UNI_1506

Details and patient eligibility

About

A 48-week, single-center, randomized, patient & evaluator-blind, matched pairs, active-controlled, non-inferiority, confirmatory design

Enrollment

65 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects who desire temporary improvement of both nasolabial folds and who has rated 3 or 4 on the Wrinkle Severity Rating Scale (WSRS) (the rating does not have to be the same for both sides)
Subjects who have agreed to discontinue all dermatological treatments or procedures, including those for facial wrinkles improvement in the facial area, during the clinical trial period
Subjects capable of understanding and complying with directions and who can participation for the full duration of the clinical trial period
Subjects who have voluntarily decided to participate in the clinical trial and have given written consent by signing the subject informed consent form

Exclusion criteria

Subjects who have been administered an antithrombotic agent (with the exception of low dosage aspirin (100mg, maximum 300mg/day)) within 2 weeks of the date of the screening
Subjects who have had a history of any bleeding disorder, in the past or the present