Clinical trial

Pilot Study of Appropriate Dosing for Reducing and Removing Hyaluronic Acid Filler With Hyaluronidase: A Randomized Control Clinical Trial

Name
STU68166
Description
The purpose of this study is to find how much hyaluronidase should be used when receiving injections of fillers.
Trial arms
Trial start
2012-10-01
Estimated PCD
2024-12-01
Trial end
2024-12-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Hyaluronidase
Arms:
Dose of Hyaluronidase
Size
5
Primary endpoint
Dose of hyaluronidase injected until the filler is no longer detectable
2 weeks
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 5, 'type': 'ESTIMATED'}}
Updated at
2024-02-05

1 organization

1 product

1 indication

Indication
Drug Safety