Restylane Refyne for Correction of Horizontal Neck Rhytides

• Status: Not yet recruiting
• Trial end date: 2020-06-01
• Target enrollment: 20
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Siperstein Dermatology
• Collaborator: Galderma
• Treatments: Hyaluronic Acid

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