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

Not Applicable

Completed

• Conditions: Tinea Pedis; Mycoses; Foot Fungus; Skin Diseases; Tinea
• Interventions: Device: Biocool Footcare

• Registration Number: NCT04265521
• Lead Sponsor: Biocool AB

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 available

Study Timeline

• Study First Submitted: 2020-02-07
• Study First Submitted QC: 2020-02-10
• Study First Posted: 2020-02-11
• Study Start: 2020-03-03
• Primary Completion: 2020-05-26
• Study Completion: 2020-06-25
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-12
• Last Update Posted: 2021-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biocool Footcare	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)

Primary Outcome Measures

Name	Time	Method
Symptoms of foot fungus	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)

Secondary Outcome Measures

Name	Time	Method
Dermatology Quality of Life	Baseline to end of study (3 weeks)	Dermatology Quality of Life Index
Follow-up on heel cracks, calluses and/or dry feet	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)
Frequency of negative fungual culture in combination with negative KOH test	Baseline to end of study (3 weeks)	Frequency of subjects with negative fungual culture in combination with negative KOH test
Adverse Events	Baseline to end of study (3 weeks)	Adverse Events (AE, ADE, SAE, SADE, USADE)
Tolerability assessment to BioCool Footcare (foothbath)	Baseline to end of study (3 weeks)	Tolerability assessed using a 5-point likert scale (very good, good, moderate, poor, very poor)

Trial Locations

Locations (2)

Forskningsenheten Carlanderska sjukhuset; 🇸🇪 Göteborg, Sweden

Avdelningen för klinisk prövning; 🇸🇪 Örebro, Sweden