Trial · NCT03825315

DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis

NCT03825315, Phase 2, Completed, Revance Therapeutics, Inc.; results first posted 2023-09-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis. Trials, record NCT03825315. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03825315

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis
NCT number: NCT03825315
Status: Completed
Phases: Phase 2
Enrollment: 155 participants, actual
Lead sponsor: Revance Therapeutics, Inc.
Conditions: Plantar Fasciitis
Interventions: DAXI 80 U, DAXI 120 U, Placebo
First posted: 2019-01-31
Last updated: 2023-09-21
Results first posted: 2023-09-21

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline at Week 8 in the Numeric Pain Rating Scale (NPRS) Score	Week 8	Change from baseline in the Numeric Pain Rating Scale (NPRS) score, which is recorded within 15 minutes after stepping out of bed in the morning and averaged over 5 days (defined as 4 days prior to study visit and on the study visit day), at Week 8. The outcome was measured by an 11-point scale scored from 0-10 where 0 is no pain and 10 is the worst pain imaginable.
Secondary	Change From Baseline at Week 8 in Foot Function Index (FFI)	Week 8	The Foot Function Index (FFI) is a 23 item questionnaire divided into 3 subscales measuring pain, disability, and activity restriction. The scale was scored from 0 (no pain) to 10 (worst pain imaginable). Both total and sub-scale scores are produced. The total FFI equals the average of the 3 subscale scores. Pain, disability, and activity limitation subscale scores were normalized and the range is from 0 to 100. The total FFI equals the average of the 3 subscale scores. Pain, disability, and activity limitation subscale scores range from 0 to 100.
Secondary	Proportion of Subjects With a Decrease From Baseline of >= 20% in NPRS	Week 8	For the proportion of subjects with a decrease from baseline of \>= 20% in NPRS score at Week 8

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline at Week 8 in the Numeric Pain Rating Scale (NPRS) Score	Week 8	Intent to treat population	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline at Week 8 in Foot Function Index (FFI)	Week 8	Intent to treat population	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Proportion of Subjects With a Decrease From Baseline of >= 20% in NPRS	Week 8	Intent to treat population	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group9

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline at Week 8 in the Numeric Pain Rating Scale (NPRS) Score	DAXI 80 U	-3.29	Standard Error 0.329	score on a scale
Change From Baseline at Week 8 in the Numeric Pain Rating Scale (NPRS) Score	DAXI 120 U	-3.25	Standard Error 0.298	score on a scale
Change From Baseline at Week 8 in the Numeric Pain Rating Scale (NPRS) Score	Placebo	-2.75	Standard Error 0.302	score on a scale
Change From Baseline at Week 8 in Foot Function Index (FFI)	DAXI 80 U	-29.02	Standard Error 2.202	score on a scale
Change From Baseline at Week 8 in Foot Function Index (FFI)	DAXI 120 U	-27.37	Standard Error 2.149	score on a scale
Change From Baseline at Week 8 in Foot Function Index (FFI)	Placebo	-23.63	Standard Error 2.185	score on a scale
Proportion of Subjects With a Decrease From Baseline of >= 20% in NPRS	DAXI 80 U	35		Participants
Proportion of Subjects With a Decrease From Baseline of >= 20% in NPRS	DAXI 120 U	41		Participants
Proportion of Subjects With a Decrease From Baseline of >= 20% in NPRS	Placebo	34		Participants

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	DAXI 80 U	49
Overall Study	STARTED	DAXI 120 U	54
Overall Study	STARTED	Placebo	52
Overall Study	COMPLETED	DAXI 80 U	42
Overall Study	COMPLETED	DAXI 120 U	48
Overall Study	COMPLETED	Placebo	46
Overall Study	NOT COMPLETED	DAXI 80 U	7
Overall Study	NOT COMPLETED	DAXI 120 U	6
Overall Study	NOT COMPLETED	Placebo	6

Source ClinicalTrials.gov

Adverse events24

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nasopharyngitis	Infections and infestations	DAXI 80 U	2	49	3
other	Nasopharyngitis	Infections and infestations	DAXI 120 U	3	54	3
other	Nasopharyngitis	Infections and infestations	Placebo	3	52	5
other	Influenza	Infections and infestations	DAXI 80 U	2	49	2
other	Influenza	Infections and infestations	DAXI 120 U	4	54	4
other	Influenza	Infections and infestations	Placebo	3	52	4
other	Upper respiratory tract infection	Infections and infestations	DAXI 80 U	1	49	1
other	Upper respiratory tract infection	Infections and infestations	DAXI 120 U	3	54	3
other	Upper respiratory tract infection	Infections and infestations	Placebo	2	52	2
other	Injection site pain	General disorders	DAXI 80 U	3	49	3

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	DAXI 80 U	0	49
Total, all-cause mortality	DAXI 120 U	0	54
Total, all-cause mortality	Placebo	0	52
Total, other adverse events	DAXI 80 U	7	49
Total, other adverse events	DAXI 120 U	12	54
Total, other adverse events	Placebo	10	52
Total, serious adverse events	DAXI 80 U	2	49
Total, serious adverse events	DAXI 120 U	2	54
Total, serious adverse events	Placebo	0	52

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03825315

GET https://conductscience.org/api/trials/v1/NCT03825315/events?page=2

API reference For AI assistants