search
Back to results

Study With BioCool Footcare in Subjects With Tinea Pedis Interdigitalis and Heel Cracks, Calluses and/or Dry Feet

Primary Purpose

Foot Fungus, Tinea, Tinea Pedis

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Biocool Footcare
Sponsored by
Biocool AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Foot Fungus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The subjects have to meet all of the following criteria to be eligible to participate in the clinical investigation:

  1. Signed informed consent form
  2. > 18 years of age
  3. Males and females

  4. Tinea Pedis (Athlete's foot) confirmed with total symptom score graded between 6-16 (erythema, erosions, macerations, pruritus, fissures, burning/stinging, hyperkeratosis and odour) using a 4-point severity scale (0=absent, 1=mild, 2=moderate and 3=severe). NOTE! maximum total score is 24.

    - Score of 2 (moderate) of higher required in at least 1 of the following; erythema, macerations, pruritus or odur.

  5. Score of at least 2 (moderate) required in at least one of the following: heel cracks (rhagades), calluses (hyperkeratosis) and dry feet using a 5-point severity scale (0=absent, 1=mild, 2=moderate, 3=advanced and 4=severe).
  6. Patient with confirmed mycological culture

Exclusion Criteria:

Subjects meeting any of the following criteria will not be permitted to participate in the clinical investigation:

  1. Severe tinea pedis interdigitalis (Athlete's foot) total score of severity grading >16 (signs and symptoms)
  2. Women pregnant or lactation at time of enrolment
  3. Diagnosed with Diabetes Type I or II
  4. Topical medicinal antifungal therapy within 4 weeks prior to study start
  5. Treatment with systemic anti fungal therapy including terbinafine, itraconazole or fluconazole within 6 months prior to study start
  6. Treatment with local amd/or systemic corticosteroids or immunosuppressant's within 6 weeks prior to study start
  7. Any other open wounds/lesions in the area treated with the Investigational device
  8. Participated in another Clinical Investigation/Trial the last 3 months
  9. Any other medical condition, judged by the investigator may make follow-up or investigation inappropriate

Sites / Locations

  • Forskningsenheten Carlanderska sjukhuset
  • Avdelningen för klinisk prövning

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biocool Footcare

Arm Description

Treatment regime: During week 1: Once daily for 7 days (7 doses) During week 2 and 3: Once every second day for 14 days (7 doses)

Outcomes

Primary Outcome Measures

Symptoms of foot fungus
Effective treatment rate of the eight clinical signs and symptoms (erythema, erosions, macerations, pruritus, fissures, burning/stinging, hyperkeratosis and odour) using a 4-point severity scale (0=absent, 1=mild, 2=moderate and 3=severe)

Secondary Outcome Measures

Frequency of negative fungual culture in combination with negative KOH test
Frequency of subjects with negative fungual culture in combination with negative KOH test
Tolerability assessment to BioCool Footcare (foothbath)
Tolerability assessed using a 5-point likert scale (very good, good, moderate, poor, very poor)
Follow-up on heel cracks, calluses and/or dry feet
Subject outcome on heel cracks (rhagades), calluses (hyperkeratosis) and/or dry feet using a 5-point scale (0=absent, 1=mild, 2=moderate, 3=advanced, 4=severe)
Dermatology Quality of Life
Dermatology Quality of Life Index
Adverse Events
Adverse Events (AE, ADE, SAE, SADE, USADE)

Full Information

First Posted
February 7, 2020
Last Updated
February 12, 2021
Sponsor
Biocool AB
search

1. Study Identification

Unique Protocol Identification Number
NCT04265521
Brief Title
Study With BioCool Footcare in Subjects With Tinea Pedis Interdigitalis and Heel Cracks, Calluses and/or Dry Feet
Official Title
A Prospective Single-arm Investigation to Assess the Efficacy and Safety After Using BioCool Footcare (Footbath) for 3 Weeks of Treatment in Subjects With Mild to Moderate Symptoms/Signs of Tinea Pedis Interdigitalis and Heel Cracks, Calluses and/or Dry Feet.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 3, 2020 (Actual)
Primary Completion Date
May 26, 2020 (Actual)
Study Completion Date
June 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biocool AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Fungus, Tinea, Tinea Pedis, Mycoses, Skin Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biocool Footcare
Arm Type
Experimental
Arm Description
Treatment regime: During week 1: Once daily for 7 days (7 doses) During week 2 and 3: Once every second day for 14 days (7 doses)
Intervention Type
Device
Intervention Name(s)
Biocool Footcare
Intervention Description
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.
Primary Outcome Measure Information:
Title
Symptoms of foot fungus
Description
Effective treatment rate of the eight clinical signs and symptoms (erythema, erosions, macerations, pruritus, fissures, burning/stinging, hyperkeratosis and odour) using a 4-point severity scale (0=absent, 1=mild, 2=moderate and 3=severe)
Time Frame
Baseline to end of study (3 weeks)
Secondary Outcome Measure Information:
Title
Frequency of negative fungual culture in combination with negative KOH test
Description
Frequency of subjects with negative fungual culture in combination with negative KOH test
Time Frame
Baseline to end of study (3 weeks)
Title
Tolerability assessment to BioCool Footcare (foothbath)
Description
Tolerability assessed using a 5-point likert scale (very good, good, moderate, poor, very poor)
Time Frame
Baseline to end of study (3 weeks)
Title
Follow-up on heel cracks, calluses and/or dry feet
Description
Subject outcome on heel cracks (rhagades), calluses (hyperkeratosis) and/or dry feet using a 5-point scale (0=absent, 1=mild, 2=moderate, 3=advanced, 4=severe)
Time Frame
Baseline to end of study (3 weeks)
Title
Dermatology Quality of Life
Description
Dermatology Quality of Life Index
Time Frame
Baseline to end of study (3 weeks)
Title
Adverse Events
Description
Adverse Events (AE, ADE, SAE, SADE, USADE)
Time Frame
Baseline to end of study (3 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subjects have to meet all of the following criteria to be eligible to participate in the clinical investigation: Signed informed consent form > 18 years of age Males and females Tinea Pedis (Athlete's foot) confirmed with total symptom score graded between 6-16 (erythema, erosions, macerations, pruritus, fissures, burning/stinging, hyperkeratosis and odour) using a 4-point severity scale (0=absent, 1=mild, 2=moderate and 3=severe). NOTE! maximum total score is 24. - Score of 2 (moderate) of higher required in at least 1 of the following; erythema, macerations, pruritus or odur. Score of at least 2 (moderate) required in at least one of the following: heel cracks (rhagades), calluses (hyperkeratosis) and dry feet using a 5-point severity scale (0=absent, 1=mild, 2=moderate, 3=advanced and 4=severe). Patient with confirmed mycological culture Exclusion Criteria: Subjects meeting any of the following criteria will not be permitted to participate in the clinical investigation: Severe tinea pedis interdigitalis (Athlete's foot) total score of severity grading >16 (signs and symptoms) Women pregnant or lactation at time of enrolment Diagnosed with Diabetes Type I or II Topical medicinal antifungal therapy within 4 weeks prior to study start Treatment with systemic anti fungal therapy including terbinafine, itraconazole or fluconazole within 6 months prior to study start Treatment with local amd/or systemic corticosteroids or immunosuppressant's within 6 weeks prior to study start Any other open wounds/lesions in the area treated with the Investigational device Participated in another Clinical Investigation/Trial the last 3 months Any other medical condition, judged by the investigator may make follow-up or investigation inappropriate
Facility Information:
Facility Name
Forskningsenheten Carlanderska sjukhuset
City
Göteborg
ZIP/Postal Code
40545
Country
Sweden
Facility Name
Avdelningen för klinisk prövning
City
Örebro
ZIP/Postal Code
70362
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study With BioCool Footcare in Subjects With Tinea Pedis Interdigitalis and Heel Cracks, Calluses and/or Dry Feet

We'll reach out to this number within 24 hrs