Clinical trial NCT03676686: Study With Nåva Foot Cream in Patients With Tinea Pedis Interdigitalis
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinea Pedis
Lead sponsor: Natumin Pharma AB
Sponsor class: INDUSTRY
First posted: 2018-09-19
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Effective clinical treatment rate
timeFrame: Baseline to end of study (8 weeks)
Secondary outcomes:
measure: Frequency of negative fungal culture
timeFrame: Baseline to end of study (8 weeks)
measure: Frequency of negative KOH test
timeFrame: Baseline to end of study (8 weeks)
measure: Tolerability to the device used
timeFrame: Baseline to end of study (8 weeks)
measure: Other clinical signs and symptoms
timeFrame: Baseline to end of study (8 weeks)
measure: Dermatology Quality of life
timeFrame: Baseline to end of study (8 weeks)
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Carlanderska sjukhuset
city: Skövde
country: Sweden
facility: PTC
city: Örebro
country: Sweden
facility: Univeristetssjukhuset
Study officials:
affiliation: Region Örebro Län
name: Martin Lundvall
role: PRINCIPAL_INVESTIGATOR
References: