Study With Nåva Foot Cream in Patients With Tinea Pedis Interdigitalis
Study With Nåva Foot Cream in Patients With Tinea Pedis Interdigitalis
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.
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