Adults 18 to 65, any sex, with Plantar Fasciitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline at Week 8 in the Visual Analog Scale (VAS) for Pain for the FootPrimary· 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.
Group
Value
95% CI
DaxibotulinumtoxinA 240 Units
-41.6
± 30.04
Placebo
-39.3
± 32.54
Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16Secondary· 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.
Week 1
Group
Value
95% CI
DAXI 240 U
-27.4
± 28.92
Placebo
-21.6
± 26.79
Week 2
Group
Value
95% CI
DAXI 240 U
-31.6
± 29.97
Placebo
-29.6
± 27.33
Week 4
Group
Value
95% CI
DAXI 240 U
-37.9
± 27.15
Placebo
-31.4
± 28.96
Week 8
Group
Value
95% CI
DAXI 240 U
-41.6
± 30.04
Placebo
-39.3
± 32.54
Week 16
Group
Value
95% CI
DAXI 240 U
-44.7
± 32.82
Placebo
-46.3
± 30.40
Change From Baseline Through Week 16 for the American Orthopaedic Foot and Ankle Score (AOFAS)Secondary· 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.
Week 1
Group
Value
95% CI
DAXI 240 U
12.4
± 17.56
Placebo
15.5
± 16.85
Week 2
Group
Value
95% CI
DAXI 240 U
14.3
± 20.32
Placebo
18.5
± 16.85
Week 4
Group
Value
95% CI
DAXI 240 U
19.4
± 22.76
Placebo
21.2
± 20.06
Week 8
Group
Value
95% CI
DAXI 240 U
20.4
± 23.64
Placebo
23.6
± 24.88
Week 16
Group
Value
95% CI
DAXI 240 U
25.7
± 23.41
Placebo
23.1
± 24.05
Change From Baseline Through Week 16 for the Foot and Ankle Disability IndexSecondary· 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.
Week 1
Group
Value
95% CI
DAXI 240 U
9.1
± 16.63
Placebo
14.5
± 14.87
Week 2
Group
Value
95% CI
DAXI 240 U
10.4
± 16.93
Placebo
16.5
± 14.12
Week 4
Group
Value
95% CI
DAXI 240 U
16.4
± 20.66
Placebo
19.3
± 14.21
Week 8
Group
Value
95% CI
DAXI 240 U
19.1
± 20.98
Placebo
19.7
± 15.71
Week 16
Group
Value
95% CI
DAXI 240 U
21.7
± 22.60
Placebo
23.2
± 17.86
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to week 16.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The specific aim of the study is to compare the safety and efficacy of a single administration of DaxibotulinumtoxinA for Injection versus placebo for managing plantar fasciitis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT03004248 — Safety of Single and Repeat Treatments of DaxibotulinumtoxinA for Injection for Treatment of Moderate to Severe Glabella
· Phase 3
· completed
NCT03014622 — Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines
· Phase 3
· completed
NCT03014635 — Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines
· Phase 3
· completed
Other recruiting trials for Plantar Fasciitis
Currently open trials in the same condition.
NCT07294196 — Percutaneous Electrolysis Targeting the Muscle-Fascia Chain for Treating Chronic Plantar Fasciitis in Adults
· NA
· recruiting
NCT07463794 — Comparison of Extracorporeal Shock Wave Therapy and Whole Body Vibration Therapy in Plantar Fasciitis
· NA
· active not recruiting
NCT07383558 — Effect of Additional Sural Nerve PRF in Chronic Heel Pain
· recruiting
NCT07242729 — Bone Marrow Aspirate Versus Platelet-Rich Fibrin for the Treatment of Chronic Plantar Fasciitis
· NA
· recruiting
NCT06967168 — HeEL Pain Pathways Feasibility Study
· NA
· recruiting
Other Revance Therapeutics, Inc. trials
Trials by the same sponsor.
NCT06411002 — Phase 2a Study of DaxibotulinumtoxinA-lanm for Injection in Dynamic Forehead Lines and Glabellar Lines
· Phase 2
· completed
NCT04846530 — Teosyal RHA® Histology and Intradermal Implantation Evaluation Study
· unknown
NCT04259086 — Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for Treatment of Upper Facial Lines
· Phase 2
· completed
NCT03911102 — Efficacy and Safety of Increasing Doses of DaxibotulinumtoxinA for Injection (DAXI for Injection) in the Treatment of Mo
· Phase 2
· completed
NCT03786770 — Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for Treatment of Forehead Lines (Frontalis)
· Phase 2
· completed
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Revance Therapeutics, Inc.
Last refreshed: 18 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03137407.