Restylane Refyne for Correction of Horizontal Neck Rhytides

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.

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