Restylane Refyne for Correction of Horizontal Neck Rhytides

June 18, 2026 updated by: Robyn Siperstein, Siperstein Dermatology

An Evaluator -Blinded, Split-Neck, Randomized Clinical Study Investigating the Efficacy and Safety of Restylane Refyne for Correction of Static Horizontal Neck Rhytides Utilizing Either a Cannula or Needle

Subjects with grades ranging from 1---3 on the Transverse Neck Line Scale, will be randomized to receive up to 1cc of Restylane Refyne on one side of their neck utilizing a cannula and up to 1cc of Restylane Refyne on the other side utilizing a 30--gauge needle. On Day 30, this treatment with the same left---right assignment can be repeated if optimal correction on either side has not been achieved according to the treating investigator. Subjects will return 24--48 hours after their first treatment, to fill out questionnaires, take pictures, and to be assessed by blinded evaluators regarding adverse events. Subjects will also return 30 days after their final treatment to fill out final questionnaires, take pictures, and to be assessed by blinded evaluators regarding improvement of static rhytides.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This will be a prospective, evaluator-blinded, split--neck, clinical study in which patients will be randomized to 2 groups.

The first group will receive up to 1cc of Restylane Refyne into the rhytides on the right side of the neck utilizing a 27---gauge cannula, while the left side will be injected with a sharp 30--gauge needle.

The second group will be reversed with the left side treated with Restylane Refyne utilizing a cannula and the right side treated with a sharp needle.

Both groups will be utilizing the same safety and comfort protocols established by the practice which include the use of topical numbing cream (B.L.T.), cleansing with alcohol, and a cold ice pack at the site of injection after the procedure.

Before and after the procedure a set of blinded evaluators will be grading the subjects' static horizontal neck lines using a validated 5--point grading scale. The blinded evaluators will also be grading the subjects side effects such as bruising and swelling 24---48 hours after the first treatment. A second treatment is allowed on Day 30 for those who have not achieved optimal correction. Either on Day 30 or Day 60, a final assessment with digital photography using Canfield's Vectra imaging system, along with a patient questionnaire on satisfaction, improvement (GAIS), side effects, and pain levels during and after the procedure will also be recorded.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Siperstein Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • In good general health as evidenced by medical history
  • For females of reproductive potential: use of highly effective contraception
  • Score of 1--3 on a validated transverse neck line scale3

Exclusion Criteria:

  • Subjects with allergies to hyaluronic acid filler.
  • Subjects with auto--immune conditions
  • Subjects with diabetes
  • Subjects taking anti--coagulants, diuretics, anti-histamines, or anti--inflammatory medications in the 2 weeks prior to the study or who will need to take these medications at any time during the 60 day study.
  • Subjects with any scheduled laser, light, or surgical procedures during the study, including dental surgery.
  • Subjects who had neuromodulators in the past 6 months or fillers in the previous 2 years in the neck area
  • Subjects who at any time had surgery or permanent fillers in the neck area
  • Subjects with scars, tattoos, or many skin growths in the neck area
  • Subjects unwilling or unable to sit still while an injector places Restylane Refyne in the neck
  • Subjects unwilling or unable to keep their head still during the photos
  • Subjects who are pregnant or nursing
  • Female subjects unable to take or use some form of birth control
  • Subjects with any neck bruising or swelling
  • Subjects with current skin infections, tumors, herpes outbreak or dermatitis on the neck

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment with Restylane Refyne Group 1
Treat right side with Restylane Refyne with a cannula and left side with a needle
Device: Restylane Refyne
Injection of Restylane Refyne with a cannula on one side of the neck and a 30 guage needle on the other side.
Experimental: Treatment with Restylane Refyne Group 2
Treat left side with Restylane Refyne with a cannula and right side with a needle
Device: Restylane Refyne
Injection of Restylane Refyne with a cannula on one side of the neck and a 30 guage needle on the other side.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Transverse Neck Rhytides
Time Frame: 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.
Baseline to 30 days after the last treatment, up to 60 days total

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Neck Halves With Adverse Events
Time Frame: 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
30 days
Global Aesthetic Improvement Scale
Time Frame: 30 Days after the last treatment, up to 60 days total
Global aesthetic improvement scale as rated by subjects
30 Days after the last treatment, up to 60 days total

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siperstein Dermatology

Collaborators

Galderma R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2020

Primary Completion (Actual)

January 22, 2021

Study Completion (Actual)

November 30, 2021

Study Registration Dates

First Submitted

November 11, 2019

First Submitted That Met QC Criteria

November 11, 2019

First Posted (Actual)

November 14, 2019

Study Record Updates

Last Update Posted (Actual)

July 16, 2026

Last Update Submitted That Met QC Criteria

June 18, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SipDerm

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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