Multicenter Double-Blind Randomized Split-Face Study to Evaluate Revanesse® Ultra vs Restylane® for Correction of NLF

NCT02987205 | Completed Results DMC FDA Device

• 1 other identifier: SYM2014-02
• Study Type: interventional
• Target: 163
• Locations: 0 countries
• Sites: N/A

Brief Summary

A randomized, multicenter, double blind, split-face study in subjects seeking NLF correction. Subjects were treated with Revanesse Ultra in the NLF on one side of the face and Restylane in the NLF on the other side of the face. The side of the face for each product was randomly assigned. The investigator performing the evaluations and the subject were blinded to the treatment; injections of the study product were performed by an unblinded injecting investigator.

Conditions

Nasolabial Fold Correction

Outcome Measures

Primary Outcomes (1)

• Primary Efficacy Variable is Change From Baseline to Visit 6/Week 24 in Wrinkle Severity Rating Scale (WSRS) Score

  Primary efficacy variable is change from Baseline to Visit 6/Week 24 in Wrinkle Severity Rating Scale (WSRS) - Treatment success is defined as at least a 1-grade improvement in WSRS from baseline to Week 24 WSRS Score categories: 1. Absent - No visible fold; continuous skin line. 2. Mild - Shallow but visible fold with a slight indentation; minor facial feature; implant is expected to produce a slight improvement in appearance. 3. Moderate - Moderately deep folds; clear facial feature visible at normal appearance but not when stretched; excellent correction is expected from injectable implant. 4. Severe - Very long and deep folds; prominent facial feature; less than 2 mm visible when stretched; significant improvement is expected from injectable implant. 5. Extreme - Extremely deep and long folds, detrimental to facial appearance; 2 to 4 mm visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone.

  Visit 6/Week 24

Secondary Outcomes (1)

• Secondary Efficacy Endpoints Are the Responder Rate, Percentage of *Nasolabial Folds* With Treatment Success

  Visit 6/Week 24

Other Outcomes (3)

• Other Efficacy Variables Include Change in WSRS Score

  Visit 2/Week 1, Visit 3/Week 2, Visit 4/Week 4, and Visit 5/Week 12

• Other Efficacy Variables Include Change in Patient Global Aesthetic Improvement (pGAI) Score

  Visit 2/Week 1, Visit 3/Week 2, Visit 4/Week 4, and Visit 5/Week 12

• Other Efficacy Variables Include Change in Investigator Global Aesthetic Improvement (iGAI) Score

  Visit 2/Week 1, Visit 3/Week 2, Visit 4/Week 4, and Visit 5/Week 12

Study Arms (2)

Revanesse Ultra

EXPERIMENTAL

Revanesse Ultra in the NLF on one side of the face

Device: Revanesse Ultra

Restylane

ACTIVE COMPARATOR

Restylane injection in the NLF on the other side of the face to optimal correction

Device: Restylane

Interventions

Revanesse Ultra DEVICE

NLF correction

Revanesse Ultra

Restylane DEVICE

NLF Correction

Restylane

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all of the following criteria to be eligible for the study:
• Men or women 22 years of age or older.
• Two fully visible bilateral nasolabial folds each with a Wrinkle Severity Rating Scale Score of 3 or 4 that may be corrected with an injectable dermal filler.
• 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.
• Ability to understand and comply with the requirements of the study.
• Willingness and ability to provide written informed consent.
• Agree to refrain from seeking other treatment for this condition during the study.

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from the study:
• Wrinkle Severity Rating Scale Score of ≤ 2 on the right or left nasolabial fold.
• Women who are pregnant or lactating.
• Received prior dermabrasion, facelift, or Botox below the orbital rim within 6 months (180 days) prior to entry into the study.
• Previous tissue augmentation (bulking agents) for facial wrinkles and scars within 6 months (180 days) at the proposed injection sites.
• Previous tissue augmentation with permanent implants.
• Evidence of scar-related disease or delayed healing activity within the past 1 year.
• Scars at the intended treatment sites.
• History of keloid formation or hypertrophic scars.
• Any infection or wound on the face.
• Allergic history including anaphylaxis or multiple severe allergies to natural rubber latex or lidocaine.
• Aspirin or nonsteroidal anti-inflammatory drugs within 1 week (7 days) prior to treatment.
• Concomitant anticoagulant therapy, antiplatelet therapy, or history of bleeding disorders or connective tissue disorders.
• Over-the-counter (OTC) wrinkle products or prescription wrinkle treatments within 4 weeks (28 days) prior to treatment and throughout the study.
• Immunocompromised or immunosuppressed.

Sponsors & Collaborators

• Prollenium Medical Technologies Inc.: lead

Results Point of Contact

• Title: Ario Khoshbin, President
• Organization: Prollenium Medical Technologies, Inc.

866-353-3015

Study Officials

• Michael H Gold, MD

  Tennessee Clinical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 8, 2016
• Study Start: May 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: September 1, 2016
• Last Updated: February 22, 2018
• Results First Posted: December 13, 2017

Record last verified: 2017-11