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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
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.
Forskningsenheten Carlanderska sjukhuset
Gothenburg, Sweden
Avdelningen för klinisk prövning
Örebro, Sweden
Symptoms of foot fungus
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)
Time frame: Baseline to end of study (3 weeks)
Frequency of negative fungual culture in combination with negative KOH test
Frequency of subjects with negative fungual culture in combination with negative KOH test
Time frame: Baseline to end of study (3 weeks)
Tolerability assessment to BioCool Footcare (foothbath)
Tolerability assessed using a 5-point likert scale (very good, good, moderate, poor, very poor)
Time frame: Baseline to end of study (3 weeks)
Follow-up on heel cracks, calluses and/or dry feet
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)
Time frame: Baseline to end of study (3 weeks)
Dermatology Quality of Life
Dermatology Quality of Life Index
Time frame: Baseline to end of study (3 weeks)
Adverse Events
Adverse Events (AE, ADE, SAE, SADE, USADE)
Time frame: Baseline to end of study (3 weeks)
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