Study With Nåva Foot Cream in Patients With Tinea Pedis Interdigitalis

Natumin Pharma

Status: Completed

Conditions: Tinea Pedis

Treatments: Device: Nåva Foot Cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT03676686

Nåva Foot Cream_1

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

Nåva Foot Cream

Experimental group

Description:

Topical Nåva foot cream administered twice daily.

Treatment:

Device: Nåva Foot Cream