Restylane Refyne for Correction of Horizontal Neck Rhytides (NCT04162496) | Clinical Trial Compass
CompletedNot Applicable
Restylane Refyne for Correction of Horizontal Neck Rhytides
United States26 participantsStarted 2020-08-11
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 th…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Transverse Neck Rhytides
Timeframe: Baseline to 30 days after the last treatment, up to 60 days total