NCT01722916

Brief Summary

The purpose of this study is to find how much hyaluronidase should be used when receiving injections of fillers.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Oct 2012

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 5, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2012

Completed
13.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 31, 2025

Status Verified

January 1, 2025

Enrollment Period

13.2 years

First QC Date

November 5, 2012

Last Update Submit

January 29, 2025

Conditions

Drug Safety

Outcome Measures

Primary Outcomes (1)

  • Dose of hyaluronidase injected until the filler is no longer detectable

    2 weeks

Study Arms (1)

Dose of Hyaluronidase

EXPERIMENTAL
Drug: Hyaluronidase

Interventions

HyaluronidaseDRUG
Dose of Hyaluronidase

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 and over
  • The subjects are in good health
  • The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator

You may not qualify if:

  • Under 18 years of age
  • Pregnancy or Lactation
  • Subjects who are unable to understand the protocol or to give informed consent
  • Subjects with mental illness
  • Recent Accutane use in the past 6 months
  • Subjects prone to hypertrophic and keloidal scarring
  • Subjects with tattoos and/or scars on upper medial arms (the treatment area)
  • Subjects with known hypersensitivity to hyaluronic acid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • Alam M, Hughart R, Geisler A, Paghdal K, Maisel A, Weil A, West DP, Veledar E, Poon E. Effectiveness of Low Doses of Hyaluronidase to Remove Hyaluronic Acid Filler Nodules: A Randomized Clinical Trial. JAMA Dermatol. 2018 Jul 1;154(7):765-772. doi: 10.1001/jamadermatol.2018.0515.

    PMID: 29710212DERIVED

MeSH Terms

Interventions

Hyaluronoglucosaminidase

Intervention Hierarchy (Ancestors)

Glycoside HydrolasesHydrolasesEnzymesEnzymes and CoenzymesPolysaccharide-LyasesCarbon-Oxygen LyasesLyases

Study Officials

  • Murad Alam, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Dermatology, Otolaryngology- Head and Neck Surgery and Surgery-Organ Transplantation

Study Record Dates

First Submitted

November 5, 2012

First Posted

November 7, 2012

Study Start

October 1, 2012

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

January 31, 2025

Record last verified: 2025-01

Locations

US(1)