CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 155 enrolled
Drug / intervention
DAXI 80 U +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03825315
NCT03825315Phase 2Completed
CompareCT.gov

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

Revance Therapeutics, Inc.·interventional·Posted Jan 31, 2019·Updated Sep 21, 2023

In Brief

A Phase 2 clinical trial evaluating DAXI 80 U, DAXI 120 U, and 1 other intervention for Plantar Fasciitis. Completed, enrolled 155 participants across 20 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPlantar Fasciitis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJan 31, 2019
Enrollment StartDec 31, 2018
Primary CompletionJun 4, 2020
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 7.4 years ago

Interventions

DAXI 80 Ubiological

DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 80 U (Low Dose Group)

DAXI 120 Ubiological

DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) 120 U (High Dose Group)

Placeboother

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.