NCT03825315

DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Revance Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 for the management of Plantar Fasciitis.

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.

Conditions

• Plantar Fasciitis

Interventions

Type	Name	Description
BIOLOGICAL	DAXI 80 U	DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 80 U (Low Dose Group)
BIOLOGICAL	DAXI 120 U	DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) 120 U (High Dose Group)
OTHER	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.

Timeline

• Start date: 2018-12-31
• Primary completion: 2020-06-04
• Completion: 2020-06-04
• First posted: 2019-01-31
• Last updated: 2023-09-21
• Results posted: 2023-09-21

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study