DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis
NCT ID: NCT03825315
Last Updated: 2023-09-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
155 participants
INTERVENTIONAL
2018-12-31
2020-06-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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DAXI 80 U
LOW Dose Group
DAXI 80 U
DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 80 U (Low Dose Group)
DAXI 120 U
HIGH Dose Group
DAXI 120 U
DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) 120 U (High Dose Group)
Placebo
Placebo Group.
Placebo
Placebo is a sterile lyophilized product consisting of inactive ingredients without the neurotoxin to be reconstituted with sterile, non-preserved 0.9% sodium chloride solution.
Interventions
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DAXI 80 U
DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 80 U (Low Dose Group)
DAXI 120 U
DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) 120 U (High Dose Group)
Placebo
Placebo is a sterile lyophilized product consisting of inactive ingredients without the neurotoxin to be reconstituted with sterile, non-preserved 0.9% sodium chloride solution.
Eligibility Criteria
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Inclusion Criteria
* Male or female subjects 18 to 65 years of age with diagnosis of unilateral plantar fasciitis.
* Persistent heel pain.
* Women of child bearing potential must have a negative pregnancy test at Screening and Injection Visits and must use an effective method of contraception during the course of the study.
Exclusion Criteria
* Previously suffered a partial or full thickness tear or surgery of the plantar fascia within the 5 years preceding participation in the investigation.
* Pregnant, nursing, or planning a pregnancy during the study.
* Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to first visit.
* Any condition or situation which, in the Investigator's opinion, puts the subject at significant risk, could confound the trial results, or may interfere significantly with the subject's participation in the trial.
18 Years
65 Years
ALL
No
Sponsors
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Revance Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Aung Foot Health Clinic
Tucson, Arizona, United States
Sacramento Foot and Ankle Center, Inc
Carmichael, California, United States
Bay Area Foot Care
Castro Valley, California, United States
West Coast Foot and Ankle
Huntington Beach, California, United States
Foot and Ankle Clinic
Los Angeles, California, United States
Bay Area Foot Care
San Francisco, California, United States
University Foot and Ankle Foundation
Santa Monica, California, United States
LA Podiatry Group
West Palm Beach, Florida, United States
Podiatry 1st
Belleville, Illinois, United States
Rosalind Franklin University of Medicine & Science
North Chicago, Illinois, United States
Kansas Institute of Research
Overland Park, Kansas, United States
Advanced Foot & Ankle Center
Las Vegas, Nevada, United States
Medical Research International
Oklahoma City, Oklahoma, United States
North Texas Institute of Neurology and Headache
Frisco, Texas, United States
Hermann Drive Research Hospital
Houston, Texas, United States
Futuro Clinical Trials, LLC
McAllen, Texas, United States
Strash Foot and Ankle Care
San Antonio, Texas, United States
The Podiatry Group of South Texas
San Antonio, Texas, United States
Rocky Mountain Foot and Ankle, LLC
Salt Lake City, Utah, United States
Wasatch Clinical Research
Salt Lake City, Utah, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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1820201
Identifier Type: -
Identifier Source: org_study_id
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