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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nåva Foot Cream | Experimental | Topical Nåva foot cream administered twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nåva Foot Cream | Device | Nåva Foot Cream is a Medical device (EU class IIa) for the treatment of tinea pedis, heal cracks, calluses and dry feet. |
|
| 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) |
| 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 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Lundvall | Region Örebro län | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carlanderska sjukhuset | Gothenburg | Sweden | ||||
| Univeristetssjukhuset |
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| ID | Term |
|---|---|
| D014008 | Tinea Pedis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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| 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) |
| Örebro |
| Sweden |
| PTC | Skövde | Sweden |
| D007239 |
| Infections |
| D012874 | Skin Diseases, Infectious |
| D005533 | Foot Dermatoses |
| D005534 | Foot Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011537 | Pruritus |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |