A prospective, open post-market clinical investigation that will enroll male and female subjects diagnosed with foot fungus and at least one of the following conditions: heal cracks, calluses and/or dry feet. The investigation population will consist of 48 subjects fulfilling the eligibility criteria for the clinical investigation. The subjects will all be treated with the study product, Nåva Foot Cream. The duration of the investigation is estimated to 6 months, including a 2-month recruitment period and 2-month follow up period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Nåva Foot Cream is a Medical device (EU class IIa) for the treatment of tinea pedis, heal cracks, calluses and dry feet.
Carlanderska sjukhuset
Gothenburg, Sweden
Univeristetssjukhuset
Örebro, Sweden
PTC
Skövde, Sweden
Effective clinical treatment rate
Change of total mean score (TMS): Improvement of 8 clinical signs and symptoms of foot fungus calculated as the total score of all using a 4-point severity scale for each symptom.
Time frame: Baseline to end of study (8 weeks)
Frequency of negative fungal culture
Frequency of patients with negative fungal culture at end of study.
Time frame: Baseline to end of study (8 weeks)
Frequency of negative KOH test
Frequency of patients with negative KOH test at end of study
Time frame: Baseline to end of study (8 weeks)
Tolerability to the device used
Tolerability assessed using a 5-point Likert scale (very good, good, moderate, poor, and very poor)
Time frame: Baseline to end of study (8 weeks)
Other clinical signs and symptoms
• Long term follow-up (8 weeks) on patient outcomes on heel cracks(rhagades), calluses and/or dry feet (hyperkeratosis)
Time frame: Baseline to end of study (8 weeks)
Dermatology Quality of life
Dermatology QoL Index
Time frame: Baseline to end of study (8 weeks)
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