Foot Fungus, Mycoses, Skin Diseases, Tinea, Tinea Pedis
Conditions
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.
Interventions
DEVICEBiocool 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
Biocool AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms of foot fungus | Baseline to end of study (3 weeks) | 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
| Measure | Time frame | Description |
|---|---|---|
| Frequency of negative fungual culture in combination with negative KOH test | Baseline to end of study (3 weeks) | Frequency of subjects with negative fungual culture in combination with negative KOH test |
| Tolerability assessment to BioCool Footcare (foothbath) | Baseline to end of study (3 weeks) | 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 | Baseline to end of study (3 weeks) | 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 | Baseline to end of study (3 weeks) | Dermatology Quality of Life Index |
| Adverse Events | Baseline to end of study (3 weeks) | Adverse Events (AE, ADE, SAE, SADE, USADE) |
Countries
Sweden
Outcome results
None listed