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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biocool Footcare | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biocool Footcare | Device | 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. |
| 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) |
| 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) |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forskningsenheten Carlanderska sjukhuset | Gothenburg | 40545 | Sweden | |||
| Avdelningen för klinisk prövning |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 18, 2022 | |
| Reset | Jul 6, 2022 | |
| Release | Oct 11, 2022 | |
| Reset | Aug 23, 2023 | |
| Release | Oct 17, 2024 | |
| Reset | Dec 5, 2024 | |
| Release | Jan 9, 2025 | |
| Reset | Jan 31, 2025 | |
| Release | Aug 14, 2025 | |
| Reset | Sep 3, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 18, 2022 | Jul 6, 2022 | |||
| Oct 11, 2022 |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D014008 | Tinea Pedis |
| D009181 | Mycoses |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D003881 | Dermatomycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
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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) |
| Örebro |
| 70362 |
| Sweden |
| Aug 23, 2023 |
| Oct 17, 2024 | Dec 5, 2024 |
| Jan 9, 2025 | Jan 31, 2025 |
| Aug 14, 2025 | Sep 3, 2025 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D005533 | Foot Dermatoses |
| D005534 | Foot Diseases |
| D011537 | Pruritus |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |