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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-23

Study Completion Date

2017-07-28

Brief Summary

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

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Detailed Description

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Conditions

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Nasolabial Fold

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Test Device - UNIVELO Sub-Q

UNIVELO Sub-Q

Group Type EXPERIMENTAL

UNIVELO Sub-Q 2mL

Intervention Type DEVICE

Test device

Comparator Device - Restylane Sub-Q

Restylane Sub-Q

Group Type ACTIVE_COMPARATOR

Restylane Sub-Q 2mL

Intervention Type DEVICE

Comparator Device

Interventions

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UNIVELO Sub-Q 2mL

Test device

Intervention Type DEVICE

Restylane Sub-Q 2mL

Comparator Device

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No