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Completed

NCT Number: NCT02654522

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

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.

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Key information

Conditions

Dermal Filler

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hylenex

Drug

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).

Other names: Hyaluronidase

Primary outcomes

  1. Cutaneous Augmentation Grading Scale (Vartanian et al, 2005)

    Time frame: 2-6 hours post initial injection

Secondary outcomes

  1. Photography (Volar Aspect) at Site of Injection

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

  2. 3-dimensional (3-D) ultrasound imaging

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

Sponsors and collaborators

Lead sponsor

Steve Yoelin M.D. Medical Associates, Inc.

Other

Registry information

Official study 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.

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 13, 2016
Registry last updated
May 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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