AgingNCT04162496
Restylane Refyne for Correction of Horizontal Neck Rhytides
A study testing Restylane Refyne in people with Aging and Wrinkle, run by Siperstein Dermatology at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Restylane Refyne
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2020to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Siperstein Dermatology
Boynton Beach, Florida, 33472
About this study
Official title: 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.
Read the 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.
- Being tested
- Restylane Refyne
- Keywords
- Hyaluronic Acid Filler, Neck Rhytides, Transverse Neck Lines, Tech Neck, Necklace Lines, Restylane, Restylane Refyne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane RefyneDevice
Injection of Restylane Refyne with a cannula on one side of the neck and a 30 guage needle on the other side.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Restylane Refyne Group 1 | Experimental | Treat right side with Restylane Refyne with a cannula and left side with a needle Receives: Device: Restylane Refyne |
| Treatment with Restylane Refyne Group 2 | Experimental | Treat left side with Restylane Refyne with a cannula and right side with a needle Receives: Device: Restylane Refyne |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Transverse Neck Rhytides
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.
Measured: Baseline to 30 days after the last treatment, up to 60 days total
Secondary outcomes (2)
Number of Neck Halves With Adverse Events
The number of reported adverse events and the difference between the two sides of the neck in the mean number of adverse events
Measured: 30 days
Global Aesthetic Improvement Scale
Global aesthetic improvement scale as rated by subjects
Measured: 30 Days after the last treatment, up to 60 days total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start11 Aug 2020
- Primary completion22 Jan 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siperstein Dermatology
- Sponsor type
- University, hospital or other
- Collaborators
- Galderma R&D
- Responsible party
- Principal investigator, Robyn Siperstein, Siperstein Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162496
- Sponsor's protocol ID
- SipDerm
- Status last verified
- Jun 2026
- First submitted
- 11 Nov 2019
- Last updated
- 16 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04162496
- Acronym / sponsor ID
- SipDerm
- Keywords
- Hyaluronic Acid Filler, Neck Rhytides, Transverse Neck Lines, Tech Neck, Necklace Lines, Restylane, Restylane Refyne
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Siperstein DermatologyUniversity, hospital or other
- Collaborators
- Galderma R&D
- Study start
- 11 Aug 2020 (actual)
- Primary completion
- 22 Jan 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 14 Nov 2019 (actual)
- Results
- Posted 16 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with Restylane Refyne Group 1 | Experimental | Device: Restylane RefyneTreat right side with Restylane Refyne with a cannula and left side with a needle |
| Treatment with Restylane Refyne Group 2 | Experimental | Device: Restylane RefyneTreat left side with Restylane Refyne with a cannula and right side with a needle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restylane RefyneInjection of Restylane Refyne with a cannula on one side of the neck and a 30 guage needle on the other side. | Device | Treatment with Restylane Refyne Group 1, Treatment with Restylane Refyne Group 2 |
Primary outcome
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.
2 secondary outcomes
Number of Neck Halves With Adverse Events
Time frame: 30 days
Global Aesthetic Improvement Scale
Time frame: 30 Days after the last treatment, up to 60 days total
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restylane Refyne in people with Aging and Wrinkle, run by Siperstein Dermatology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Transverse Neck Rhytides (time frame: Baseline to 30 days after the last treatment, up to 60 days total). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.