Tinea Pedis
Conditions
Brief summary
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.
Interventions
DEVICENåva Foot Cream
Nåva Foot Cream is a Medical device (EU class IIa) for the treatment of tinea pedis, heal cracks, calluses and dry feet.
Sponsors
Natumin Pharma AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed Informed Consent Form 2. \> 18 years of age 3. Tinea pedis (Athlete's foot) confirmed with positive mycological culture for a dermatophyte 4. Total score of 6-16 when grading the eight sign and symptoms of tinea pedis (erythema, erosions, macerations, pruritus, fissures, burning/stinging, hyperkeratosis, odour) using a 4-point severity scale (0=absent, 1= mild, 2= moderate, 3=severe) o Score of 2 or higher required in at least one of the following: erythema, pruritus, macerations or odour 5. Score of at least 2 (moderate) required in at least one of the following: heel cracks (rhagades), calluses and dry feet (hyperkeratosis) using a 5-point severity scale (0=absent, 1= mild, 2= moderate, 3= advanced, 4=severe) age
Exclusion criteria
1. Patients with negative mycological culture 2. Severe tinea pedis interdigitalis (Athlete's foot) total score of grading sign and symptoms \> 16 3. Women pregnant or lactation at time of enrolment 4. Patients using medicinal topical antifungal therapy within 4 weeks prior to study start 5. Treatment with oral terbinafine, itraconazole or fluconazole within 6 months prior to start of study 6. Treatment with other systemic antifungals within 12 weeks prior to start of study 7. Treatment with systemic corticosteroids or immunosuppressants within 6 weeks prior to start of study 8. Any other condition that as judged by the investigator may make follow-up or investigations inappropriate 9. Any patient that according to the Declaration of Helsinki is unsuitable for enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effective clinical treatment rate | Baseline to end of study (8 weeks) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of negative fungal culture | Baseline to end of study (8 weeks) | Frequency of patients with negative fungal culture at end of study. |
| Frequency of negative KOH test | Baseline to end of study (8 weeks) | Frequency of patients with negative KOH test at end of study |
| Tolerability to the device used | Baseline to end of study (8 weeks) | Tolerability assessed using a 5-point Likert scale (very good, good, moderate, poor, and very poor) |
| Other clinical signs and symptoms | Baseline to end of study (8 weeks) | • Long term follow-up (8 weeks) on patient outcomes on heel cracks(rhagades), calluses and/or dry feet (hyperkeratosis) |
| Dermatology Quality of life | Baseline to end of study (8 weeks) | Dermatology QoL Index |
Countries
Sweden
Outcome results
None listed