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

Skin Diseases Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04265521
• Other study ID #: BioC001
• Status: Completed
• Phase: N/A
• Start date: March 3, 2020
• Est. completion date: June 25, 2020

Study information

• Verified date: February 2021
• Source: Biocool AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 25, 2020
• Est. primary completion date: May 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

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.

Locations

Country	Name	City	State
Sweden	Forskningsenheten Carlanderska sjukhuset	Göteborg
Sweden	Avdelningen för klinisk prövning	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Biocool AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	Dermatology Quality of Life	Dermatology Quality of Life Index	Baseline to end of study (3 weeks)
Secondary	Adverse Events	Adverse Events (AE, ADE, SAE, SADE, USADE)	Baseline to end of study (3 weeks)