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

The Use of a Recombinant DNA-based Hyaluronidase (RDNAH/ Hylenex Recombinant) to Dissolve Fixed Amounts of a Variety of Popular Hyaluronic Acid (HA) Dermal Fillers in Human Subjects.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02654522

Enrollment

Registered

2016-01-13

Start date

2016-01-31

Completion date

2016-02-29

Last updated

2017-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermal Filler

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.

Interventions

DRUGHylenex

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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026