Clinical trial NCT04265521: Study With BioCool Footcare in Subjects With Tinea Pedis Interdigitalis and Heel Cracks, Calluses and/or Dry Feet
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Foot Fungus
Tinea
Tinea Pedis
Mycoses
Skin Diseases
Lead sponsor: Biocool AB
Sponsor class: INDUSTRY
First posted: 2020-02-11
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Symptoms of foot fungus
timeFrame: Baseline to end of study (3 weeks)
Secondary outcomes:
measure: Frequency of negative fungual culture in combination with negative KOH test
timeFrame: Baseline to end of study (3 weeks)
measure: Tolerability assessment to BioCool Footcare (foothbath)
timeFrame: Baseline to end of study (3 weeks)
measure: Follow-up on heel cracks, calluses and/or dry feet
timeFrame: Baseline to end of study (3 weeks)
measure: Dermatology Quality of Life
timeFrame: Baseline to end of study (3 weeks)
measure: Adverse Events
timeFrame: Baseline to end of study (3 weeks)
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Forskningsenheten Carlanderska sjukhuset
city: Örebro
country: Sweden
facility: Avdelningen för klinisk prövning
Study officials:
References: