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

Phase 1

Completed

• Conditions: Dermal Filler
• Interventions: Drug: Hylenex

• Registration Number: NCT02654522
• Lead Sponsor: Steve Yoelin M.D. Medical Associates, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-11
• Study First Submitted QC: 2016-01-12
• Study First Posted: 2016-01-13
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Filler	Hylenex	Each subject will have one product in one forearm and another product in the other. Products: JUVEDERM Ultra Plus (24 mg/mL of HA) and VOLUMA (20 mg/mL of HA). Subjects will be randomized as to which forearm will receive which product. In one forearm, subject will receive four injections of the assigned HA filler (0.2mL). HA injections will be placed along a line from the wrist to the antecubital fossa. The initial 0.2mL HA injection will be placed in the deep dermis 5 cm from the wrist and the subsequent three 0.2mL HA injections will be place in 5 cm increments in the deep dermis along the line noted above. Same process will be used on the contralateral forearm using the other HA filler.1-3 hours post injection, these 8 HA injection sites (4 per forearm) per subject will then receive a randomized amount of Hylenex recombinant (0U, 30U, 60U or 75U).

Primary Outcome Measures

Name	Time	Method
Cutaneous Augmentation Grading Scale (Vartanian et al, 2005)	2-6 hours post initial injection

Secondary Outcome Measures

Name	Time	Method
Photography (Volar Aspect) at Site of Injection	1-6 hours post initial injection day 1, day 2
3-dimensional (3-D) ultrasound imaging	1-6 hours post initial injection day 1, day 2