NCT07150273

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 23, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2017

Completed
8.1 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 2, 2025

Completed
Last Updated

September 8, 2025

Status Verified

August 1, 2025

Enrollment Period

1.1 years

First QC Date

August 24, 2025

Last Update Submit

August 31, 2025

Conditions

Nasolabial Fold

Outcome Measures

Primary Outcomes (1)

  • Wrinkle Severity Rating Scale (WSRS)

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

    24 weeks

Secondary Outcomes (2)

  • Wrinkle Severity Rating Scale (WSRS)

    8 weeks, 16 weeks, 36 weeks, 48 weeks

  • Global Aesthetic Improvement Scale (GAIS)

    8 weeks, 16 weeks, 24 weeks, 36 weeks, 48 weeks

Study Arms (2)

Test Device - UNIVELO Sub-Q

EXPERIMENTAL

UNIVELO Sub-Q

Device: UNIVELO Sub-Q 2mL

Comparator Device - Restylane Sub-Q

ACTIVE COMPARATOR

Restylane Sub-Q

Device: Restylane Sub-Q 2mL

Interventions

UNIVELO Sub-Q 2mLDEVICE

Test device

Test Device - UNIVELO Sub-Q
Restylane Sub-Q 2mLDEVICE

Comparator Device

Comparator Device - Restylane Sub-Q

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2025

First Posted

September 2, 2025

Study Start

February 23, 2016

Primary Completion

March 23, 2017

Study Completion

July 28, 2017

Last Updated

September 8, 2025

Record last verified: 2025-08