Study With BioCool Footcare in Subjects With Tinea Pedis Interdigitalis and Heel Cracks, Calluses and/or Dry Feet
NCT04265521 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2021-02-15
Summary
A prospective, open, post-market study that will enroll male and female subjects diagnosed with foot fungus and at least one of the following conditions: heel cracks, calluses and/or dry feet. The investigation will consist of approximately 48 subjects (considering a 10% drop-out/screening failure rate) fulfilling the eligibility criteria for the study. Each subject will be treated with the study product, BioCool Footcare (footbath), for 3 weeks. The study duration is estimated to 5 months including recruiting, treatment and follow-up period.
Conditions
- Foot Fungus
- Tinea
- Tinea Pedis
- Mycoses
- Skin Diseases
Interventions
- DEVICE
-
Biocool Footcare
BioCool Footcare is a footbath containing granulate of sodium percarbonate that will in this study be used for treatment of foot fungus, heel cracks, calluses and/or dry feet.
Sponsors & Collaborators
-
Biocool AB
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-03-03
- Primary Completion
- 2020-05-26
- Completion
- 2020-06-25
Countries
- Sweden
Study Locations
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