Study With NÃ¥va Foot Cream in Patients With Tinea Pedis Interdigitalis (NCT03676686) | Clinical Trial Compass
CompletedNot Applicable
Study With NÃ¥va Foot Cream in Patients With Tinea Pedis Interdigitalis
Sweden46 participantsStarted 2018-10-01
Plain-language 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, NÃ¥va Foot Cream. The duration of the investigation is estimated to 6 months, including a 2-month recruitment period and 2-month follow up period.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Signed Informed Consent Form
✓. \> 18 years of age
✓. Tinea pedis (Athlete's foot) confirmed with positive mycological culture for a dermatophyte
✓. 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)
✓. 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
✕. Patients with negative mycological culture
✕. Severe tinea pedis interdigitalis (Athlete's foot) total score of grading sign and symptoms \> 16
✕. Women pregnant or lactation at time of enrolment
✕. Patients using medicinal topical antifungal therapy within 4 weeks prior to study start
✕. Treatment with oral terbinafine, itraconazole or fluconazole within 6 months prior to start of study
✕. Treatment with other systemic antifungals within 12 weeks prior to start of study
✕. Treatment with systemic corticosteroids or immunosuppressants within 6 weeks prior to start of study