NCT04162496

Restylane Refyne for Correction of Horizontal Neck Rhytides

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Siperstein Dermatology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Aging
• Wrinkle
• Rhytides

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-08-11
• Primary completion: 2021-01-22
• Completion: 2021-09-30
• First posted: 2019-11-14
• Last updated: 2021-06-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study