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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Foot Fungus, Tinea, Tinea Pedis, Mycoses, Skin Diseases

Intervention / Treatment
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* Device: Biocool Footcare


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biocool Footcare<br>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) | Device: Biocool Footcare<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Baseline to end of study (3 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of negative fungual culture in combination with negative KOH test | Frequency of subjects with negative fungual culture in combination with negative KOH test | Baseline to end of study (3 weeks) | 
| Tolerability assessment to BioCool Footcare (foothbath) | Tolerability assessed using a 5-point likert scale (very good, good, moderate, poor, very poor) | Baseline to end of study (3 weeks) | 
| 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) | Baseline to end of study (3 weeks) | 
| Dermatology Quality of Life | Dermatology Quality of Life Index | Baseline to end of study (3 weeks) | 
| Adverse Events | Adverse Events (AE, ADE, SAE, SADE, USADE) | Baseline to end of study (3 weeks) |