Trial Outcomes & Findings for Multicenter Double-Blind Randomized Split-Face Study to Evaluate Revanesse® Ultra vs Restylane® for Correction of NLF (NCT NCT02987205)

Last Updated: 2018-02-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

163 participants

Primary outcome timeframe

Visit 6/Week 24

Results posted on

2018-02-22

Participant Flow

Participant milestones

Participant milestones
Measure	Bilateral Treatment With Revanesse Ultra and Restylane Randomized treatment with Revanesse Ultra in the Nasolabial Fold (NLF) on one side of the face, and Restylane on the opposite side of the face - the study is 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.
Overall Study STARTED	163
Overall Study Treated - Bilateral NLF Injection	163
Overall Study COMPLETED	159
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Bilateral Treatment With Revanesse Ultra and Restylane Randomized treatment with Revanesse Ultra in the Nasolabial Fold (NLF) on one side of the face, and Restylane on the opposite side of the face - the study is 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.
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Split Face Study Bilateral Revanesse Ultra vs Restylane in NLF n=326 NLF Treatments Split face study - Revanesse Ultra in the NLF on one side of the face and Restylane on the opposite side of the face for NLF correction, treatment is randomized
Age, Continuous	55.4 years STANDARD_DEVIATION 10.16 • n=5 Participants
Age, Customized 22 to <40 years	15 Participants n=5 Participants
Age, Customized 40 to <64 years	110 Participants n=5 Participants
Age, Customized 64 to <75 years	35 Participants n=5 Participants
Age, Customized = or >75 years	3 Participants n=5 Participants
Sex: Female, Male Female	156 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	146 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	154 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Fitzpatrick Skin Type (FST) Classification FST I	3 Participants n=5 Participants
Fitzpatrick Skin Type (FST) Classification FST II	50 Participants n=5 Participants
Fitzpatrick Skin Type (FST) Classification FST III	83 Participants n=5 Participants
Fitzpatrick Skin Type (FST) Classification FST IV	16 Participants n=5 Participants
Fitzpatrick Skin Type (FST) Classification FST V	4 Participants n=5 Participants
Fitzpatrick Skin Type (FST) Classification FST VI	7 Participants n=5 Participants
Body Mass Index (BMI)	26.27 kg/m^2 STANDARD_DEVIATION 5.374 • n=5 Participants

PRIMARY outcome

Timeframe: Visit 6/Week 24

Population: Analysis of effectiveness based on Per Protocol analysis which includes 125 evaluable patients at 24 weeks.

Outcome measures

Outcome measures
Measure	Revanesse Ultra n=125 Nasolabial Folds Revanesse Ultra in the NLF on one side of the face Revanesse Ultra: NLF correction	Restylane n=125 Nasolabial Folds Restylane injection in the NLF on the other side of the face to optimal correction Restylane: NLF Correction
Primary Efficacy Variable is Change From Baseline to Visit 6/Week 24 in Wrinkle Severity Rating Scale (WSRS) Score	1.02 scores on a scale Interval 0.902 to 1.146	0.91 scores on a scale Interval 0.777 to 1.047

SECONDARY outcome

Timeframe: Visit 6/Week 24

Population: Per-Protocol (PP) Population

Treatment success (defined as at least a 1-grade improvement in WSRS from baseline to Week 24): The WSRS Score is a 5-point scale. The WSRS score was assessed for each NLF at every study visit through Visit 6/Week 24 by a blinded evaluator (blinded to the treatment assignment of each NLF).

Outcome measures

Outcome measures
Measure	Revanesse Ultra n=125 Nasolabial Folds Revanesse Ultra in the NLF on one side of the face Revanesse Ultra: NLF correction	Restylane n=125 Nasolabial Folds Restylane injection in the NLF on the other side of the face to optimal correction Restylane: NLF Correction
Secondary Efficacy Endpoints Are the Responder Rate, Percentage of Nasolabial Folds With Treatment Success	98 Nasolabial Folds	91 Nasolabial Folds

OTHER_PRE_SPECIFIED outcome

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

Treatment success is (defined as at least a 1-grade improvement in WSRS from baseline to Week 24)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

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

Treatment success is (defined as at least a 1-grade improvement in WSRS from baseline to Week 24)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

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

Treatment success is (defined as at least a 1-grade improvement in WSRS from baseline to Week 24)

Outcome measures

Outcome data not reported

Adverse Events

Revanesse Ultra

Serious events: 0 serious events

Other events: 114 other events

Deaths: 0 deaths

Restylane

Serious events: 1 serious events

Other events: 137 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Revanesse Ultra n=163 participants at risk Revanesse Ultra in the NLF on one side of the face Revanesse Ultra: NLF correction	Restylane n=163 participants at risk Restylane injection in the NLF on the other side of the face to optimal correction Restylane: NLF Correction
General disorders Treatment emergent Injection site vascular complication	0.00% 0/163 • 24 weeks Treatment safety was evaluated by frequency and percent of subjects and investigators reporting treatment-emergent adverse events (TEAEs) tabulated by treatment group, location, frequency, severity and duration after each treatment (initial treatment, touch up) and throughout the study. TEAEs were assessed by a subject diary after each injection, touch up and follow up visit, and were reported by the Evaluating Investigator at each of the follow-up visits	0.61% 1/163 • Number of events 1 • 24 weeks Treatment safety was evaluated by frequency and percent of subjects and investigators reporting treatment-emergent adverse events (TEAEs) tabulated by treatment group, location, frequency, severity and duration after each treatment (initial treatment, touch up) and throughout the study. TEAEs were assessed by a subject diary after each injection, touch up and follow up visit, and were reported by the Evaluating Investigator at each of the follow-up visits

Other adverse events

Other adverse events
Measure	Revanesse Ultra n=163 participants at risk Revanesse Ultra in the NLF on one side of the face Revanesse Ultra: NLF correction	Restylane n=163 participants at risk Restylane injection in the NLF on the other side of the face to optimal correction Restylane: NLF Correction
General disorders INJECTION SITE HAEMATOMA	50.3% 82/163 • Number of events 106 • 24 weeks Treatment safety was evaluated by frequency and percent of subjects and investigators reporting treatment-emergent adverse events (TEAEs) tabulated by treatment group, location, frequency, severity and duration after each treatment (initial treatment, touch up) and throughout the study. TEAEs were assessed by a subject diary after each injection, touch up and follow up visit, and were reported by the Evaluating Investigator at each of the follow-up visits	47.2% 77/163 • Number of events 95 • 24 weeks Treatment safety was evaluated by frequency and percent of subjects and investigators reporting treatment-emergent adverse events (TEAEs) tabulated by treatment group, location, frequency, severity and duration after each treatment (initial treatment, touch up) and throughout the study. TEAEs were assessed by a subject diary after each injection, touch up and follow up visit, and were reported by the Evaluating Investigator at each of the follow-up visits
General disorders INJECTION SITE SWELLING	47.2% 77/163 • Number of events 102 • 24 weeks Treatment safety was evaluated by frequency and percent of subjects and investigators reporting treatment-emergent adverse events (TEAEs) tabulated by treatment group, location, frequency, severity and duration after each treatment (initial treatment, touch up) and throughout the study. TEAEs were assessed by a subject diary after each injection, touch up and follow up visit, and were reported by the Evaluating Investigator at each of the follow-up visits	71.2% 116/163 • Number of events 163 • 24 weeks Treatment safety was evaluated by frequency and percent of subjects and investigators reporting treatment-emergent adverse events (TEAEs) tabulated by treatment group, location, frequency, severity and duration after each treatment (initial treatment, touch up) and throughout the study. TEAEs were assessed by a subject diary after each injection, touch up and follow up visit, and were reported by the Evaluating Investigator at each of the follow-up visits
General disorders INJECTION SITE PAIN	38.0% 62/163 • Number of events 103 • 24 weeks Treatment safety was evaluated by frequency and percent of subjects and investigators reporting treatment-emergent adverse events (TEAEs) tabulated by treatment group, location, frequency, severity and duration after each treatment (initial treatment, touch up) and throughout the study. TEAEs were assessed by a subject diary after each injection, touch up and follow up visit, and were reported by the Evaluating Investigator at each of the follow-up visits	66.3% 108/163 • Number of events 192 • 24 weeks Treatment safety was evaluated by frequency and percent of subjects and investigators reporting treatment-emergent adverse events (TEAEs) tabulated by treatment group, location, frequency, severity and duration after each treatment (initial treatment, touch up) and throughout the study. TEAEs were assessed by a subject diary after each injection, touch up and follow up visit, and were reported by the Evaluating Investigator at each of the follow-up visits
General disorders INJECTION SITE ERYTHEMA	21.5% 35/163 • Number of events 44 • 24 weeks Treatment safety was evaluated by frequency and percent of subjects and investigators reporting treatment-emergent adverse events (TEAEs) tabulated by treatment group, location, frequency, severity and duration after each treatment (initial treatment, touch up) and throughout the study. TEAEs were assessed by a subject diary after each injection, touch up and follow up visit, and were reported by the Evaluating Investigator at each of the follow-up visits	31.9% 52/163 • Number of events 65 • 24 weeks Treatment safety was evaluated by frequency and percent of subjects and investigators reporting treatment-emergent adverse events (TEAEs) tabulated by treatment group, location, frequency, severity and duration after each treatment (initial treatment, touch up) and throughout the study. TEAEs were assessed by a subject diary after each injection, touch up and follow up visit, and were reported by the Evaluating Investigator at each of the follow-up visits

Additional Information

Ario Khoshbin, President

Prollenium Medical Technologies, Inc.

Phone: 866-353-3015

Results disclosure agreements

Principal investigator is a sponsor employee There are restrictions within the site contracts that the sites cannot publish any results and also have confidentiality agreements in place separately that restrict any publications by sites regarding results, findings, etc.
Publication restrictions are in place

Restriction type: OTHER