DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis

Revance Therapeutics

Status and phase: Completed; Phase 2

Conditions: Plantar Fasciitis

Treatments: Biological: DAXI 80 U; Biological: DAXI 120 U; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03825315

1820201

Details and patient eligibility

About

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.

Full description

Approximately 150 subjects, recruited from approximately 20 study centers in the United States (US) will be randomized to DAXI (HIGH-dose; LOW-dose) or placebo group, respectively.

Enrollment: 155 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent, including authorization to release health information.
• Male or female subjects 18 to 65 years of age with diagnosis of unilateral plantar fasciitis.
• Persistent heel pain.
• Women of child bearing potential must have a negative pregnancy test at Screening and Injection Visits and must use an effective method of contraception during the course of the study.

Exclusion criteria

• Previous injection of botulinum toxin in the lower extremities or feet.
• Previously suffered a partial or full thickness tear or surgery of the plantar fascia within the 5 years preceding participation in the investigation.
• Pregnant, nursing, or planning a pregnancy during the study.
• Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to first visit.
• Any condition or situation which, in the Investigator's opinion, puts the subject at significant risk, could confound the trial results, or may interfere significantly with the subject's participation in the trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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155 participants in 3 patient groups, including a placebo group

DAXI 80 U

Experimental group

Description:

LOW Dose Group

Treatment:

Biological: DAXI 80 U

DAXI 120 U

Experimental group

Description:

HIGH Dose Group

Treatment:

Biological: DAXI 120 U

Placebo

Placebo Comparator group

Description:

Placebo Group.

Treatment:

Other: Placebo