Status:
COMPLETED
DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis
Lead Sponsor:
Revance Therapeutics, Inc.
Conditions:
Plantar Fasciitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This is a randomized, double-blind, placebo-controlled, parallel group, multi-center trial of a single administration of DaxibotulinumtoxinA (DAXI) (high-dose; low-dose) for injection versus placebo f...
Detailed Description
Approximately 150 subjects, recruited from approximately 20 study centers in the United States (US) will be randomized to DAXI (HIGH-dose; LOW-dose) or placebo group, respectively.
Eligibility Criteria
Inclusion
- Written informed consent, including authorization to release health information.
- 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
- Previous injection of botulinum toxin in the lower extremities or feet.
- 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.
Key Trial Info
Start Date :
December 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2020
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT03825315
Start Date
December 31 2018
End Date
June 4 2020
Last Update
September 21 2023
Active Locations (20)
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1
Aung Foot Health Clinic
Tucson, Arizona, United States, 85710
2
Sacramento Foot and Ankle Center, Inc
Carmichael, California, United States, 95608
3
Bay Area Foot Care
Castro Valley, California, United States, 94546
4
West Coast Foot and Ankle
Huntington Beach, California, United States, 92648