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Reducing and Removing Hyaluronic Acid Filler With Hyaluronidase

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01722916
Recruitment Status : Active, not recruiting
First Posted : November 7, 2012
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University

Tracking Information
First Submitted Date  ICMJE November 5, 2012
First Posted Date  ICMJE November 7, 2012
Last Update Posted Date February 15, 2019
Study Start Date  ICMJE October 2012
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2012)
Dose of hyaluronidase injected until the filler is no longer detectable [ Time Frame: 2 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01722916 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reducing and Removing Hyaluronic Acid Filler With Hyaluronidase
Official Title  ICMJE Pilot Study of Appropriate Dosing for Reducing and Removing Hyaluronic Acid Filler With Hyaluronidase: A Randomized Control Clinical Trial
Brief Summary The purpose of this study is to find how much hyaluronidase should be used when receiving injections of fillers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Drug Safety
Intervention  ICMJE Drug: Hyaluronidase
Study Arms  ICMJE Experimental: Dose of Hyaluronidase
Intervention: Drug: Hyaluronidase
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 5, 2012)
5
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01722916
Other Study ID Numbers  ICMJE STU68166
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Murad Alam, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Murad Alam, MD Northwestern University
PRS Account Northwestern University
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP