Nåva Foot Cream

About this trial

Last updated 5 years ago

Study ID

Nåva Foot Cream_1

Status

Completed

Type

Interventional

Phase

N/A

Placebo

Accepting

18+ Years

All

Not accepting

Healthy Volunteers

Trial Timing

Ended 6 years ago

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.

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

Study With Nåva Foot Cream in Patients With Tinea Pedis Interdigitalis