Trial Outcomes & Findings for Restylane Refyne for Correction of Horizontal Neck Rhytides (NCT NCT04162496)

Results Overview

Difference in the mean absolute change from baseline on a 5--point validated transverse neck line scale. The lowest score 0 signifies no line and a better outcome while the highest score 4 signifies a worse outcome.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

26 participants

Primary outcome timeframe

Baseline to 30 days after the last treatment, up to 60 days total

Results posted on

2026-07-16

Participant Flow

Subjects with neck lines ranging from 1 to 3 on the TNLS

Qualified based on inclusion and exclusion criteria

Participant milestones

Participant milestones
Measure	Treatment With Restylane Refyne Group 1 Treat right side with Restylane Refyne with a cannula and left side with a needle Restylane Refyne: Injection of Restylane Refyne with a cannula on one side of the neck and a 30 guage needle on the other side.	Treatment With Restylane Refyne Group 2 Treat left side with Restylane Refyne with a cannula and right side with a needle Restylane Refyne: Injection of Restylane Refyne with a cannula on one side of the neck and a 30 guage needle on the other side.	Control Group 1 Treat right side with cannula and left side with needle both with saline	Control Group 2 Treat left side with cannula and right side with needle, both with saline
Overall Study STARTED	10	10	3	3
Overall Study COMPLETED	9	9	3	3
Overall Study NOT COMPLETED	1	1	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Restylane Refyne n=20 Participants Injection Restylane Refyne	Control n=6 Participants Injection with saline	Total n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=20 Participants	0 Participants n=6 Participants	0 Participants n=26 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=20 Participants	5 Participants n=6 Participants	22 Participants n=26 Participants
Age, Categorical >=65 years	3 Participants n=20 Participants	1 Participants n=6 Participants	4 Participants n=26 Participants
Sex: Female, Male Female	19 Participants n=20 Participants	5 Participants n=6 Participants	24 Participants n=26 Participants
Sex: Female, Male Male	1 Participants n=20 Participants	1 Participants n=6 Participants	2 Participants n=26 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	20 Participants n=20 Participants	6 Participants n=6 Participants	26 Participants n=26 Participants
Transverse Neck Line Score (TNLS)	2.7 units on a scale n=20 Participants	2.6 units on a scale n=6 Participants	2.7 units on a scale n=26 Participants

PRIMARY outcome

Timeframe: Baseline to 30 days after the last treatment, up to 60 days total

Difference in the mean absolute change from baseline on a 5--point validated transverse neck line scale. The lowest score 0 signifies no line and a better outcome while the highest score 4 signifies a worse outcome.

Outcome measures

Outcome measures
Measure	Treatment With Restylane Refyne Cannula n=20 Neck Halves Treat with Restylane Refyne with a 27 gauge cannula	Treatment With Restylane Refyne Needle n=20 Neck Halves Treat with Restylane Refyne with a 30 guage needle	Control Cannula n=6 Neck Halves Treat with cannula using saline	Control Needle n=6 Neck Halves Treat with needle using saline
Change in Transverse Neck Rhytides	1.15 score on a scale Interval 0.0 to 3.0	1.9 score on a scale Interval 0.0 to 3.0	0 score on a scale Interval 0.0 to 0.0	0.33 score on a scale Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: 30 days

The number of reported adverse events and the difference between the two sides of the neck in the mean number of adverse events

Outcome measures

Outcome measures
Measure	Treatment With Restylane Refyne Cannula n=20 neck halves Treat with Restylane Refyne with a 27 gauge cannula	Treatment With Restylane Refyne Needle n=20 neck halves Treat with Restylane Refyne with a 30 guage needle	Control Cannula n=6 neck halves Treat with cannula using saline	Control Needle n=6 neck halves Treat with needle using saline
Number of Neck Halves With Adverse Events lumps	7 neck halves	14 neck halves	0 neck halves	0 neck halves
Number of Neck Halves With Adverse Events pain	6 neck halves	8 neck halves	0 neck halves	0 neck halves
Number of Neck Halves With Adverse Events swelling	11 neck halves	12 neck halves	0 neck halves	0 neck halves
Number of Neck Halves With Adverse Events bruising	13 neck halves	9 neck halves	1 neck halves	0 neck halves
Number of Neck Halves With Adverse Events Itching	4 neck halves	2 neck halves	0 neck halves	0 neck halves

SECONDARY outcome

Timeframe: 30 Days after the last treatment, up to 60 days total

Population: Number of participants rating themselves as 2 or 3 on GAIS (much or very much improved)

Global aesthetic improvement scale as rated by subjects

Outcome measures

Outcome measures
Measure	Treatment With Restylane Refyne Cannula n=20 neck halves Treat with Restylane Refyne with a 27 gauge cannula	Treatment With Restylane Refyne Needle n=20 neck halves Treat with Restylane Refyne with a 30 guage needle	Control Cannula n=6 neck halves Treat with cannula using saline	Control Needle n=6 neck halves Treat with needle using saline
Global Aesthetic Improvement Scale	13 participants	17 participants	2 participants	2 participants

Adverse Events

Needle Refyne

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Cannula Refyne

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Needle Saline

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cannula Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Needle Refyne n=20 participants at risk Injection with a 30 guage needle in one neck half with Refyne	Cannula Refyne n=20 participants at risk Injection with a 27 gauge cannula in one neck half with Refyne	Needle Saline n=6 participants at risk Injection with a 30g needle with saline	Cannula Saline n=6 participants at risk Injection with a 27g cannula saline
Skin and subcutaneous tissue disorders Pain	30.0% 6/20 • Number of events 6 • 1 year for all subjects Blind evaluators, subject questionnaires and subject diaries were used to collect adverse events	40.0% 8/20 • Number of events 8 • 1 year for all subjects Blind evaluators, subject questionnaires and subject diaries were used to collect adverse events	0.00% 0/6 • 1 year for all subjects Blind evaluators, subject questionnaires and subject diaries were used to collect adverse events	0.00% 0/6 • 1 year for all subjects Blind evaluators, subject questionnaires and subject diaries were used to collect adverse events
Skin and subcutaneous tissue disorders Swelling	55.0% 11/20 • Number of events 11 • 1 year for all subjects Blind evaluators, subject questionnaires and subject diaries were used to collect adverse events	60.0% 12/20 • Number of events 12 • 1 year for all subjects Blind evaluators, subject questionnaires and subject diaries were used to collect adverse events	0.00% 0/6 • 1 year for all subjects Blind evaluators, subject questionnaires and subject diaries were used to collect adverse events	0.00% 0/6 • 1 year for all subjects Blind evaluators, subject questionnaires and subject diaries were used to collect adverse events
Skin and subcutaneous tissue disorders Bruising	65.0% 13/20 • Number of events 14 • 1 year for all subjects Blind evaluators, subject questionnaires and subject diaries were used to collect adverse events	45.0% 9/20 • Number of events 9 • 1 year for all subjects Blind evaluators, subject questionnaires and subject diaries were used to collect adverse events	16.7% 1/6 • 1 year for all subjects Blind evaluators, subject questionnaires and subject diaries were used to collect adverse events	0.00% 0/6 • 1 year for all subjects Blind evaluators, subject questionnaires and subject diaries were used to collect adverse events
Skin and subcutaneous tissue disorders Itching	20.0% 4/20 • Number of events 4 • 1 year for all subjects Blind evaluators, subject questionnaires and subject diaries were used to collect adverse events	10.0% 2/20 • Number of events 2 • 1 year for all subjects Blind evaluators, subject questionnaires and subject diaries were used to collect adverse events	0.00% 0/6 • 1 year for all subjects Blind evaluators, subject questionnaires and subject diaries were used to collect adverse events	0.00% 0/6 • 1 year for all subjects Blind evaluators, subject questionnaires and subject diaries were used to collect adverse events
Skin and subcutaneous tissue disorders Lump	35.0% 7/20 • Number of events 7 • 1 year for all subjects Blind evaluators, subject questionnaires and subject diaries were used to collect adverse events	70.0% 14/20 • Number of events 14 • 1 year for all subjects Blind evaluators, subject questionnaires and subject diaries were used to collect adverse events	0.00% 0/6 • 1 year for all subjects Blind evaluators, subject questionnaires and subject diaries were used to collect adverse events	0.00% 0/6 • 1 year for all subjects Blind evaluators, subject questionnaires and subject diaries were used to collect adverse events

Additional Information

Robyn Siperstein, MD

Siperstein Dermatology Group

Phone: 9544941400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place