Trial Outcomes & Findings for Restylane Defyne Compared to Restylane for Correction of Moderate to Severe Nasolabial Folds (NCT NCT03003130)

Last Updated: 2023-11-03

Results Overview

The Wrinkle Severity Rating Scale (WSRS) is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. Grade 1 Absent: No visible fold; continuous skin line Grade 2 Mild: Shallow but visible fold with a slight indentation; minor facial feature Implant is expected to produce a slight improvement in appearance Grade 3 Moderate: Moderately deep folds; clear facial feature visible at normal appearance but not when stretched. Excellent correction is expected from injectable implant Grade 4 Severe: Very long and deep fold; prominent facial feature; less than 2-mm visible fold when stretched Significant improvement is expected from injectable implant Grade 5 Extreme: Extremely deep and long fold; detrimental to facial appearance; 2- to 4-mm V-shaped fold when stretched. Unlikely to have satisfactory correction with injectable implant alone

Recruitment status

COMPLETED

Study phase

Target enrollment

175 participants

Primary outcome timeframe

6 month

Results posted on

2023-11-03

Participant Flow

Each subject have 2 NLFs, the right/left one. According to protocol that Each subject will be randomized to one of two treatment sequences; either Restylane Defyne in the right NLF followed by Restylane in the left NLF, or Restylane in the right NLF followed by Restylane Defyne in the left NLF. Arms/Groups are combined because right/left side is not statistical factors.

Participant milestones

Participant milestones
Measure	Restylane Defyne in the Right NLF Followed by Restylane in the Left NLF Restylane Defyne treated in the right NLF followed by Restylane in the left NLF	Restylane in the Right NLF Followed by Restylane Defyne in the Left NLF Restylane treated in the right NLF followed by Restylane Defyne in the left NLF
Overall Study STARTED	88	87
Overall Study COMPLETED	80	80
Overall Study NOT COMPLETED	8	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Restylane Defyne Compared to Restylane for Correction of Moderate to Severe Nasolabial Folds

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Restylane Defyne in the Right NLF Followed by Restylane in the Left NLF n=88 Participants Restylane Defyne treated in the right NLF followed by Restylane in the left NLF	Restylane in the Right NLF Followed by Restylane Defyne in the Left NLF n=87 Participants Restylane treated in the right NLF followed by Restylane Defyne in the left NLF	Total n=175 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	88 Participants n=5 Participants	86 Participants n=7 Participants	174 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	44 years STANDARD_DEVIATION 8.7 • n=5 Participants	44 years STANDARD_DEVIATION 8.7 • n=7 Participants	NA years STANDARD_DEVIATION NA • n=5 Participants
Sex: Female, Male Female	83 Participants n=5 Participants	83 Participants n=7 Participants	166 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	88 Participants n=5 Participants	87 Participants n=7 Participants	175 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment China	88 participants n=5 Participants	87 participants n=7 Participants	175 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 month

Outcome measures

Outcome measures
Measure	Restylane Defyne in the Right NLF Followed by Restylane in the Left NLF n=87 Participants Restylane Defyne treated in the right NLF followed by Restylane in the left NLF	Restylane in the Right NLF Followed by Restylane Defyne in the Left NLF n=86 Participants Restylane treated in the right NLF followed by Restylane Defyne in the left NLF
Percentage of Responders, Defined by at Least 1-point Improvement From Baseline on the WSRS.	72.9 percentage of subjects Interval 66.3 to 79.6	72.8 percentage of subjects Interval 66.1 to 79.5

Adverse Events

Restylane Defyne

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Restylane

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Restylane Defyne n=175 participants at risk Since all participants received both Restylane and Restylane Defyne treatments, the appropriate way to present Adverse Events to include two Arms eflecting all participants who received each intervention during the study.	Restylane n=175 participants at risk Since all participants received both Restylane and Restylane Defyne treatments, the appropriate way to present Adverse Events to include two Arms eflecting all participants who received each intervention during the study.
Eye disorders Retinal detachment*	0.57% 1/175 • Number of events 1 • 1 year. According to the subject's treatment randomization.Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be: "Since your last clinical visit have you had any health problems?", and or obtained from signs and symptoms from examination, lab test, self observations, diary or spontaneous reports from subject. Since each subject will receive Restylane and Restylane Defyne, then AE was collected per subject, not per intervention.	0.57% 1/175 • Number of events 1 • 1 year. According to the subject's treatment randomization.Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be: "Since your last clinical visit have you had any health problems?", and or obtained from signs and symptoms from examination, lab test, self observations, diary or spontaneous reports from subject. Since each subject will receive Restylane and Restylane Defyne, then AE was collected per subject, not per intervention.
Injury, poisoning and procedural complications Traumatic arthritis	0.57% 1/175 • Number of events 1 • 1 year. According to the subject's treatment randomization.Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be: "Since your last clinical visit have you had any health problems?", and or obtained from signs and symptoms from examination, lab test, self observations, diary or spontaneous reports from subject. Since each subject will receive Restylane and Restylane Defyne, then AE was collected per subject, not per intervention.	0.57% 1/175 • Number of events 1 • 1 year. According to the subject's treatment randomization.Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be: "Since your last clinical visit have you had any health problems?", and or obtained from signs and symptoms from examination, lab test, self observations, diary or spontaneous reports from subject. Since each subject will receive Restylane and Restylane Defyne, then AE was collected per subject, not per intervention.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.57% 1/175 • Number of events 1 • 1 year. According to the subject's treatment randomization.Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be: "Since your last clinical visit have you had any health problems?", and or obtained from signs and symptoms from examination, lab test, self observations, diary or spontaneous reports from subject. Since each subject will receive Restylane and Restylane Defyne, then AE was collected per subject, not per intervention.	0.57% 1/175 • Number of events 1 • 1 year. According to the subject's treatment randomization.Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be: "Since your last clinical visit have you had any health problems?", and or obtained from signs and symptoms from examination, lab test, self observations, diary or spontaneous reports from subject. Since each subject will receive Restylane and Restylane Defyne, then AE was collected per subject, not per intervention.

Other adverse events

Adverse event data not reported

Additional Information

Head of Development

Q-Med AB

Phone: + 46 (0) 18 474 90 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place