MedTrace Logo

DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis

NCT03825315 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2023-09-21

Study results available
· View outcomes & findings →

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.

Conditions

  • Plantar Fasciitis

Interventions

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.

Sponsors & Collaborators

  • Revance Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-31
Primary Completion
2020-06-04
Completion
2020-06-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03825315 on ClinicalTrials.gov