DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis



Status:Recruiting
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 65
Updated:3/29/2019
Start Date:December 31, 2018
End Date:April 2020
Contact:Daniel Snyder, PhD
Email:dsnyder@revance.com
Phone:510-742-3523

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A Phase II, Prospective, Randomized, Double-Blind, Multi-center, Placebo-Controlled Trial of DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis

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 for the management of Plantar Fasciitis.

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.

Inclusion Criteria:

- 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 Criteria:

- 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.
We found this trial at
9
sites
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North Chicago, IL
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Houston, Texas 77004
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Houston, TX
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Las Vegas, Nevada 89119
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Las Vegas, NV
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McAllen, Texas 78501
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McAllen, TX
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Overland Park, Kansas 66211
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Overland Park, KS
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San Antonio, Texas 78229
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San Antonio, TX
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Santa Monica, California 90403
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Santa Monica, CA
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Tucson, Arizona 85710
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Tucson, AZ
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West Palm Beach, Florida 33406
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West Palm Beach, FL
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