The Use of a Recombinant DNA-based Hyaluronidase to Dissolve Fixed Amounts of Hyaluronic Acid Dermal Fillers

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether or not Recombinant DNA-based hyaluronidase (RDNAH/Hylenex recombinant), is safe and effective for dissolving hyaluronic acid (HA) dermal fillers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Steve Yoelin M.D. Medical Associates, Inc.
• Treatments: Hyaluronic Acid

Criteria

Inclusion Criteria:

• Male or female 18 years of age or older

• Able to speak/write in the English language

• Negative Pregnancy Test on Day 1

• Proposed injection site must be free of any active inflammation

Exclusion Criteria:

• Pregnant or breast feeding

• History of keloid formation

• History of allergic reaction to hyaluronic acid dermal fillers, hyaluronidase, or any ingredients of the aforementioned products

• Active, uncontrolled inflammatory condition of any type

• History of allergic reaction to lidocaine