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Study to Evaluate Safety and Efficacy of Revanesse® Ultra + vs Revanesse® Ultra for Correction of NLF | Clinical Trials | Clareo Health

COMPLETEDNA

Study to Evaluate Safety and Efficacy of Revanesse® Ultra + vs Revanesse® Ultra for Correction of NLF

A Multicenter, Double-Blind, Randomized, Split-Face Study to Evaluate the Safety and Efficacy of Revanesse® Ultra + (With Lidocaine) Versus Revanesse® Ultra for the Correction of Nasolabial Folds (NLF)

NCT02991040•Prollenium Medical Technologies Inc.

View on ClinicalTrials.gov

Summary

A Multicenter, Double-Blind, Randomized, Split-Face Study to Evaluate the Safety and Efficacy of Revanesse® Ultra + (with Lidocaine) versus Revanesse® Ultra for the Correction of Nasolabial Folds to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine, hereafter referred to as Revanesse Ultra +) to Revanesse Ultra for subjects undergoing correction of nasolabial folds (NLFs)

Detailed Description

This is a randomized, multicenter, double-blind, split-face study in subjects seeking nasolabial fold correction. Subjects will be treated with Revanesse Ultra + in the NLF on one side of the face and Revanesse Ultra in the NLF on the other side of the face. The side of the face for each study product will be randomly assigned. The investigator and the subject will be blinded to the treatment; injections of the study product will be performed by an unblinded injecting investigator. At each visit, investigator and subject evaluations of the treated areas will be performed and recorded

Eligibility

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subjects must meet all of the following criteria to be eligible for the study:
•1. Men or women 22 years of age or older seeking augmentation therapy for correction of bilateral nasolabial folds.
•2. Two fully visible bilateral nasolabial folds each with a Wrinkle Severity Rating Scale Score (WSRS) of 3 or 4 that may be corrected with an injectable dermal filler. The NLFs should be symmetrical, i.e., WSRS scores at NLFs on both sides should be the same (both Moderate \[3\] or both Severe \[4\]).
•3. If female and of childbearing potential, a negative urine pregnancy test and agree to use adequate contraception. Female subjects of childbearing potential (excluding women who are surgically sterilized or postmenopausal for at least 2 years) must have a negative urine pregnancy test and must be willing to use a medically accepted method of contraception during the study. The following are considered acceptable methods of birth control for the purpose of this study: oral contraceptives, contraceptive patches, contraceptive implant, vaginal contraceptive, double barrier methods (e.g., condom and spermicide), contraceptive injection (Depo-Provera®), intrauterine device (IUD), hormonal IUD (Mirena®), and abstinence with a documented second acceptable method of birth control if the subject becomes sexually active. Subjects entering the study who are on hormonal contraceptives must have been on the method for at least 90 days prior to the study and continue the method for the duration of the study. Subjects who had used hormonal contraception and stopped must have stopped no less than 90 days prior to Visit 1/Day 1.
•4. Ability to understand and comply with the requirements of the study.
•5. Willingness and ability to provide written informed consent. 6. Agree to refrain from seeking other treatment for this condition during the study.

Exclusion Criteria

•Subjects who meet any of the following criteria will be excluded from the study:
•1. Wrinkle Severity Rating Scale Score of ≤ 2 on the right or left nasolabial fold.
•2. Women who are pregnant or lactating.
•3. Received prior dermabrasion, facelift, or Botox below the orbital rim, or had undergone procedures based on active dermal response (e.g., laser or chemical peeling procedures) within 6 months (180 days) prior to study entry.
•4. Use of any facial tissue augmenting therapy with non-permanent filler or aesthetic facial surgical therapy within 9 months prior to study entry.
•5. Has ever received semi-permanent fillers anywhere in the face or neck, or is planning to be implanted with these products during the study.
•6. Has a permanent implant placed in the NLF area.
•7. Evidence of scar-related disease or delayed healing activity within the past 1 year.
•8. Scars at the intended treatment sites.
•9. History of keloid formation or hypertrophic scars.
+12 more criteria

Locations (1)

Tennessee Clinical Research Center

Nashville, Tennessee, United States

Key Dates

Start Date

August 1, 2016

Primary Completion Date

August 1, 2017

Completion Date

August 1, 2017

Last Updated

April 11, 2019

Enrollment

100

ACTUAL participants

Conditions

Nasolabial Fold Correction

Interventions

Revanesse Ultra+ (with lidocaine)

DEVICE

Revanesse Ultra

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 11, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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