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