Restylane Refyne for Correction of Horizontal Neck Rhytides

NCT ID: NCT04162496

Last Updated: 2021-06-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-11
• Study Completion Date: 2021-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment with Restylane Refyne Group 1

Treat right side with Restylane Refyne with a cannula and left side with a needle

Group Type: EXPERIMENTAL

Restylane Refyne

Intervention Type: DEVICE

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

Group Type: EXPERIMENTAL

Restylane Refyne

Intervention Type: DEVICE

Injection of Restylane Refyne with a cannula on one side of the neck and a 30 guage needle on the other side.

Interventions

Restylane Refyne

Injection of Restylane Refyne with a cannula on one side of the neck and a 30 guage needle on the other side.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: collaborator

Siperstein Dermatology

OTHER

Sponsor Role: lead

Responsible Party

Robyn Siperstein

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Siperstein Dermatology

Boynton Beach, Florida, United States

Countries

United States

Other Identifiers

SipDerm

Identifier Type: -

Identifier Source: org_study_id