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

• ClinicalTrials.gov Identifier: NCT04265521
• Recruitment Status: Completed
• First Posted: February 11, 2020
• Last Update Posted: February 15, 2021
• Sponsor: Biocool AB
• Information provided by (Responsible Party): Biocool AB

Tracking Information

• First Submitted Date: February 7, 2020
• First Posted Date: February 11, 2020
• Last Update Posted Date: February 15, 2021
• Actual Study Start Date: March 3, 2020
• Actual Primary Completion Date: May 26, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 10, 2020)

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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 10, 2020)

• Frequency of negative fungual culture in combination with negative KOH test [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline to end of study (3 weeks) ]
  Dermatology Quality of Life Index
• Adverse Events [ Time Frame: Baseline to end of study (3 weeks) ]
  Adverse Events (AE, ADE, SAE, SADE, USADE)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Foot Fungus
• Tinea
• Tinea Pedis
• Mycoses
• Skin Diseases

Intervention

Device: Biocool 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.

Study Arms

Experimental: Biocool Footcare

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: Device: Biocool Footcare

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 12, 2021): 25
• Original Estimated Enrollment (submitted: February 10, 2020): 48
• Actual Study Completion Date: June 25, 2020
• Actual Primary Completion Date: May 26, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT04265521
• Other Study ID Numbers: BioC001
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Biocool AB
• Original Responsible Party: Same as current
• Current Study Sponsor: Biocool AB
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Biocool AB
• Verification Date: February 2021