Foot FungusNCT04265521
Study With BioCool Footcare in Subjects With Tinea Pedis Interdigitalis and Heel Cracks, Calluses and/or Dry Feet
A study testing Biocool Footcare in people with Foot Fungus and Tinea, run by Biocool AB at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Fungus, Tinea, Tinea Pedis
- What is being tested?
- Biocool Footcare
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesSweden
- Study dates
- 3 Mar 2020to 25 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Forskningsenheten Carlanderska sjukhuset
Gothenburg, 40545
Avdelningen för klinisk prövning
Örebro, 70362
About this study
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.
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
- Being tested
- Biocool Footcare
- Medical subject headings
- Tinea, Tinea Pedis, Mycoses, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biocool FootcareDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: Biocool Footcare |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline to end of study (3 weeks)
Secondary outcomes (5)
Frequency of negative fungual culture in combination with negative KOH test
Frequency of subjects with negative fungual culture in combination with negative KOH test
Measured: 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)
Measured: 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)
Measured: Baseline to end of study (3 weeks)
Dermatology Quality of Life
Dermatology Quality of Life Index
Measured: Baseline to end of study (3 weeks)
Adverse Events
Adverse Events (AE, ADE, SAE, SADE, USADE)
Measured: Baseline to end of study (3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start3 Mar 2020
- Primary completion26 May 2020
- Study completion25 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot FungusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocool AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265521
- Sponsor's protocol ID
- BioC001
- Status last verified
- Feb 2021
- First submitted
- 7 Feb 2020
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04265521
- Acronym / sponsor ID
- BioC001
- Conditions
- Foot Fungus, Tinea, Tinea Pedis, Mycoses, Skin Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Biocool ABIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 26 May 2020 (actual)
- Study completion
- 25 Jun 2020 (actual)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biocool Footcare | Experimental | Device: Biocool FootcareTreatment 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biocool FootcareBioCool 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. | Device | Biocool Footcare |
Primary outcome
Symptoms of foot fungus
Time frame: 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)
5 secondary outcomes
Frequency of negative fungual culture in combination with negative KOH test
Time frame: Baseline to end of study (3 weeks)
Tolerability assessment to BioCool Footcare (foothbath)
Time frame: Baseline to end of study (3 weeks)
Follow-up on heel cracks, calluses and/or dry feet
Time frame: Baseline to end of study (3 weeks)
Dermatology Quality of Life
Time frame: Baseline to end of study (3 weeks)
Adverse Events
Time frame: Baseline to end of study (3 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biocool Footcare in people with Foot Fungus and Tinea, run by Biocool AB at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms of foot fungus (time frame: Baseline to end of study (3 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2021; AzTrials last refreshed its copy on 6 Nov 2026.