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

NCT02654522 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-05-16

No results posted yet for this study

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.

Conditions

  • Dermal Filler

Interventions

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).

Sponsors & Collaborators

  • Steve Yoelin M.D. Medical Associates, Inc.

    lead OTHER

Principal Investigators

  • Steven G Yoelin, M.D. · Steve Yoelin M.D. Medical Associates, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-02-29
Completion
2016-02-29

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02654522 on ClinicalTrials.gov