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

Dermal Filler Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02654522
• Other study ID #: HH101
• Status: Completed
• Phase: Phase 1
• First received: January 11, 2016
• Last updated: May 15, 2017
• Start date: January 2016
• Est. completion date: February 2016

Study information

• Verified date: May 2017
• Source: Steve Yoelin M.D. Medical Associates, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dermal Filler

Intervention

Drug:
• Hylenex
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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Steve Yoelin M.D. Medical Associates, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cutaneous Augmentation Grading Scale (Vartanian et al, 2005)		2-6 hours post initial injection
Secondary	Photography (Volar Aspect) at Site of Injection		1-6 hours post initial injection day 1, day 2
Secondary	3-dimensional (3-D) ultrasound imaging		1-6 hours post initial injection day 1, day 2