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

Not Applicable

Completed

• Conditions: Nasolabial Fold

• Registration Number: NCT07150273
• Lead Sponsor: Jetema Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-23
• Primary Completion: 2017-03-23
• Study Completion: 2017-07-28
• Status Verified: 2025-08
• Study First Submitted: 2025-08-24
• Study First Submitted QC: 2025-08-24
• Last Update Submitted: 2025-08-31
• Study First Posted: 2025-09-02
• Last Update Posted: 2025-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Wrinkle Severity Rating Scale (WSRS)	24 weeks	Measure severity of wrinkle from score of 1 (no visible fold) to 5 (extremely deep and long folds)

Secondary Outcome Measures

Name	Time	Method
Wrinkle Severity Rating Scale (WSRS)	8 weeks, 16 weeks, 36 weeks, 48 weeks	Measure severity of wrinkle from score of 1 (no visible fold) to 5 (extremely deep and long folds)
Global Aesthetic Improvement Scale (GAIS)	8 weeks, 16 weeks, 24 weeks, 36 weeks, 48 weeks	Measure improvement status of wrinkle from score of -1 (worse) to 3 (very much improved)