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

Steve Yoelin M.D. Medical Associates, Inc.15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dermal Filler

Interventions

HylenexDRUG

1-3 hours post injection, the 8 HA injection sites (4 per forearm) per subject will then receive a randomized amount of Hylenex recombinant (0U, 30U, 60U or 75U).

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Cutaneous Augmentation Grading Scale (Vartanian et al, 2005)

Time frame: 2-6 hours post initial injection

Secondary Outcomes

Photography (Volar Aspect) at Site of Injection

Time frame: 1-6 hours post initial injection day 1, day 2

3-dimensional (3-D) ultrasound imaging

Time frame: 1-6 hours post initial injection day 1, day 2

Data from ClinicalTrials.gov

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