Restylane Refyne for Correction of Horizontal Neck Rhytides

NCT04162496 | Active Not Recruiting FDA Device

• 1 other identifier: SipDerm
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Wrinkle; Rhytides

Keywords

Hyaluronic Acid Filler; Neck Rhytides; Transverse Neck Lines; Tech Neck; Necklace Lines; Restylane; Restylane Refyne

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 30 days after the last treament

Secondary Outcomes (2)

• Adverse Events

  Day 1 to Day 30

• Global Aesthetic Improvement Scale

  30 Days after the last treatment

Study Arms (2)

Treatment with Restylane Refyne Group 1

EXPERIMENTAL

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

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

Device: Restylane Refyne

Interventions

Restylane Refyne 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 1; Treatment with Restylane Refyne Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Siperstein Dermatology: lead
• Galderma R&D: collaborator

Study Sites (1)

Siperstein Dermatology

Boynton Beach, Florida, 33472, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 14, 2019
• Study Start: August 11, 2020
• Primary Completion: January 22, 2021
• Study Completion: September 30, 2021
• Last Updated: June 8, 2021

Record last verified: 2021-06

Locations

US (1)