Study With Nåva Foot Cream in Patients With Tinea Pedis Interdigitalis

Launched by NATUMIN PHARMA AB · Sep 17, 2018

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Eligibility criteria

• 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