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

Biocool

Status: Completed

Conditions: Tinea Pedis; Tinea; Foot Fungus; Skin Diseases; Mycoses

Treatments: Device: Biocool Footcare

Study type: Interventional

Funder types: Industry

Identifiers

NCT04265521

BioC001

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Biocool Footcare

Experimental group

Description:

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)

Treatment:

Device: Biocool Footcare