Phase 2 DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis

Revance Therapeutics

Status and phase: Completed; Phase 2

Conditions: Plantar Fasciitis

Treatments: Biological: Botulinum Toxins, Type A; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03137407

1720201

Details and patient eligibility

About

The specific aim of the study is to compare the safety and efficacy of a single administration of DaxibotulinumtoxinA for Injection versus placebo for managing plantar fasciitis.

Enrollment: 59 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent, including authorization to release health information
• Male or female subjects 18 to 65 years of age with diagnosis of plantar fasciitis
• Persistent heel pain for more than three months
• Women of child bearing potential must have negative pregnancy test at Screening and Injection Visits and must use an effective method of birth control during the course of the study

Exclusion criteria

• Previous surgery on the midfoot or hindfoot
• Neuromuscular disease
• Systemic muscle weakness
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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59 participants in 2 patient groups, including a placebo group

DAXI 240 U

Experimental group

Description:

DaxibotulinumtoxinA for injection for the treatment of plantar fasciitis (PF) with 240 U

Treatment:

Biological: Botulinum Toxins, Type A

Placebo

Placebo Comparator group

Description:

Placebo Intramuscular Injection

Treatment:

Biological: Placebo