Trial · NCT03137407

Phase 2 DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis

NCT03137407, Phase 2, Completed, Revance Therapeutics, Inc.; results first posted 2023-08-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase 2 DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis. Trials, record NCT03137407. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03137407

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Trial

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

Title: Phase 2 DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis
NCT number: NCT03137407
Status: Completed
Phases: Phase 2
Enrollment: 59 participants, actual
Lead sponsor: Revance Therapeutics, Inc.
Conditions: Plantar Fasciitis
Interventions: Botulinum Toxins, Type A, Placebo
First posted: 2017-05-02
Last updated: 2023-09-18
Results first posted: 2023-08-28

Source ClinicalTrials.gov

Registered outcomes4

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 Visual Analog Scale (VAS) for Pain for the Foot	Week 8	The primary efficacy endpoint, as identified in the Statistical Analysis Plan (SAP) was the change from baseline in the visual analog scale (VAS) for pain for the affected foot at Week 8. The outcome was measured by means of a 100 mm VAS (0= no pain, 100= maximum pain) and higher reduction from baseline VAS pain scores means a better outcome.
Secondary	Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16	Weeks 1, 2, 4, 8, and 16	Reduction in foot pain was assessed as the change from baseline in the Visual Analog Scale (VAS) at weeks 1, 2, 4, 8, and 16. The outcome was measured by means of a 100 mm VAS (0= no pain, 100= maximum pain) and higher reduction from baseline VAS pain scores means a better outcome.
Secondary	Change From Baseline Through Week 16 for the American Orthopaedic Foot and Ankle Score (AOFAS)	Weeks 1, 2, 4, 8, and 16	The American Orthopaedic Foot and Ankle Score (AOFAS) measures foot and ankle conditions in 3 categories, pain, function, and alignment. The scale includes 9 items and the total score ranges from a minimum of 0 to a maximum of 100, with higher scores indicating a better outcome.
Secondary	Change From Baseline Through Week 16 for the Foot and Ankle Disability Index	Weeks 1, 2, 4, 8, and 16	The Foot and Ankle Disability Index is a 26 item questionnaire that measures disability and measures a total value minimum of 0 to a maximum of 104, with higher scores indicating greater disability.

Source ClinicalTrials.gov

Outcomes4

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 Visual Analog Scale (VAS) for Pain for the Foot	Week 8	Intent to treat population	score on a scale	MEAN
SECONDARY	Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16	Weeks 1, 2, 4, 8, and 16	Intent to treat population	score on a scale	MEAN
SECONDARY	Change From Baseline Through Week 16 for the American Orthopaedic Foot and Ankle Score (AOFAS)	Weeks 1, 2, 4, 8, and 16	Intent to treat population	score on a scale	MEAN
SECONDARY	Change From Baseline Through Week 16 for the Foot and Ankle Disability Index	Weeks 1, 2, 4, 8, and 16	Intent to treat population	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group32

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

Outcome	Group	Category	Value	Spread	Units
Change From Baseline at Week 8 in the Visual Analog Scale (VAS) for Pain for the Foot	DaxibotulinumtoxinA 240 Units		-41.6	Standard Deviation 30.04	score on a scale
Change From Baseline at Week 8 in the Visual Analog Scale (VAS) for Pain for the Foot	Placebo		-39.3	Standard Deviation 32.54	score on a scale
Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16	DAXI 240 U	Week 1	-27.4	Standard Deviation 28.92	score on a scale
Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16	Placebo	Week 1	-21.6	Standard Deviation 26.79	score on a scale
Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16	DAXI 240 U	Week 2	-31.6	Standard Deviation 29.97	score on a scale
Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16	Placebo	Week 2	-29.6	Standard Deviation 27.33	score on a scale
Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16	DAXI 240 U	Week 4	-37.9	Standard Deviation 27.15	score on a scale
Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16	Placebo	Week 4	-31.4	Standard Deviation 28.96	score on a scale
Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16	DAXI 240 U	Week 8	-41.6	Standard Deviation 30.04	score on a scale
Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16	Placebo	Week 8	-39.3	Standard Deviation 32.54	score on a scale

1 to 10 of 32Source ClinicalTrials.gov

See all 32 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	DAXI 240 U	30
Overall Study	STARTED	Placebo	29
Overall Study	COMPLETED	DAXI 240 U	26
Overall Study	COMPLETED	Placebo	23
Overall Study	NOT COMPLETED	DAXI 240 U	4
Overall Study	NOT COMPLETED	Placebo	6

Source ClinicalTrials.gov

Adverse events32

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
other	Atrioventricular block first degree	Cardiac disorders	DAXI 240 U	0	30
other	Atrioventricular block first degree	Cardiac disorders	Placebo	2	29
other	Injection Site Hemorrhage	General disorders	DAXI 240 U	3	30
other	Injection Site Hemorrhage	General disorders	Placebo	2	29
other	Injection Site Pain	General disorders	DAXI 240 U	6	30
other	Injection Site Pain	General disorders	Placebo	6	29
other	Injection site bruising	General disorders	DAXI 240 U	2	30
other	Injection site bruising	General disorders	Placebo	1	29
other	Injection site edema	General disorders	DAXI 240 U	0	30
other	Injection site edema	General disorders	Placebo	2	29

1 to 10 of 32Source ClinicalTrials.gov

See all 32 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	DAXI 240 U	0	30
Total, all-cause mortality	Placebo	0	29
Total, other adverse events	DAXI 240 U	20	30
Total, other adverse events	Placebo	16	29
Total, serious adverse events	DAXI 240 U	1	30
Total, serious adverse events	Placebo	0	29

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 comparisons2

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

Comparison	Source
DAXI 240 U vs Placebo: deaths from any cause	Trial comparisons
DAXI 240 U vs Placebo: serious adverse events	Trial comparisons

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/NCT03137407

GET https://conductscience.org/api/trials/v1/NCT03137407/results?page=2

API reference For AI assistants