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

NCT ID: NCT04265521

Last Updated: 2021-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-03
• Study Completion Date: 2020-06-25

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Biocool Footcare

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biocool AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Forskningsenheten Carlanderska sjukhuset

Gothenburg, , Sweden

Avdelningen för klinisk prövning

Örebro, , Sweden

Countries

Sweden

Other Identifiers

BioC001

Identifier Type: -

Identifier Source: org_study_id