Study With Nåva Foot Cream in Patients With Tinea Pedis Interdigitalis

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Single-arm Investigation to Assess the Efficacy, of Topical Nåva Foot Cream for 8 Weeks of Treatment in Patients With Mild to Moderate Tinea Pedis Interdigitalis and Heal Cracks, Calluses and/or Dry Feet.

Conditions
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Tinea Pedis

Intervention / Treatment
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* Device: Nåva Foot Cream


Participation Criteria
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Eligibility Criteria
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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) o Score of 2 or higher required in at least one of the following: erythema, pruritus, macerations or odour 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 Any other condition that as judged by the investigator may make follow-up or investigations inappropriate Any patient that according to the Declaration of Helsinki is unsuitable for enrollment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nåva Foot Cream<br>Topical Nåva foot cream administered twice daily. | Device: Nåva Foot Cream<br>* Nåva Foot Cream is a Medical device (EU class IIa) for the treatment of tinea pedis, heal cracks, calluses and dry feet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective clinical treatment rate | 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. | Baseline to end of study (8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of negative fungal culture | Frequency of patients with negative fungal culture at end of study. | Baseline to end of study (8 weeks) | 
| Frequency of negative KOH test | Frequency of patients with negative KOH test at end of study | Baseline to end of study (8 weeks) | 
| Tolerability to the device used | Tolerability assessed using a 5-point Likert scale (very good, good, moderate, poor, and very poor) | Baseline to end of study (8 weeks) | 
| Other clinical signs and symptoms | • Long term follow-up (8 weeks) on patient outcomes on heel cracks(rhagades), calluses and/or dry feet (hyperkeratosis) | Baseline to end of study (8 weeks) | 
| Dermatology Quality of life | Dermatology QoL Index | Baseline to end of study (8 weeks) |