NCT01722916CompletedPhase 1
Pilot Study of Appropriate Dosing for Reducing and Removing Hyaluronic Acid Filler With Hyaluronidase: A Randomized Control Clinical Trial
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Northwestern University
- Enrollment
- 5
- Locations
- 2
- Primary Endpoint
- Dose of hyaluronidase injected until the filler is no longer detectable
Study Overview
Brief Summary
The purpose of this study is to find how much hyaluronidase should be used when receiving injections of fillers.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Dose of Hyaluronidase
Experimental
Intervention: Hyaluronidase (Drug)
Outcomes
Primary Outcomes
Dose of hyaluronidase injected until the filler is no longer detectable
Time Frame: 2 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Murad Alam
Professor in Dermatology, Otolaryngology- Head and Neck Surgery and Surgery-Organ Transplantation
Northwestern University
Study Sites (2)
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