Skip to main content
OpenTrials
Completed

NCT Number: NCT07150273

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Nasolabial Fold

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UNIVELO Sub-Q 2mL

Device

Test device

Restylane Sub-Q 2mL

Device

Comparator Device

Primary outcomes

  1. Wrinkle Severity Rating Scale (WSRS)

    Time frame: 24 weeks

    Measure severity of wrinkle from score of 1 (no visible fold) to 5 (extremely deep and long folds)

Secondary outcomes

  1. Wrinkle Severity Rating Scale (WSRS)

    Time frame: 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)

  2. Global Aesthetic Improvement Scale (GAIS)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Jetema Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Single-Center, Patient & Evaluator-Blind, Matched Pairs, Active-Controlled Design Confirmatory 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 2, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.