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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03676686
Other study ID # Nåva Foot Cream_1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2018
Est. completion date November 4, 2019

Study information

Verified date February 2020
Source Natumin Pharma AB
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date November 4, 2019
Est. primary completion date November 4, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Nåva Foot Cream
Nåva Foot Cream is a Medical device (EU class IIa) for the treatment of tinea pedis, heal cracks, calluses and dry feet.

Locations

Country Name City State
Sweden Carlanderska sjukhuset Göteborg
Sweden Univeristetssjukhuset Örebro
Sweden PTC Skövde

Sponsors (1)

Lead Sponsor Collaborator
Natumin Pharma AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Frequency of negative fungal culture Frequency of patients with negative fungal culture at end of study. Baseline to end of study (8 weeks)
Secondary Frequency of negative KOH test Frequency of patients with negative KOH test at end of study Baseline to end of study (8 weeks)
Secondary 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)
Secondary 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)
Secondary Dermatology Quality of life Dermatology QoL Index Baseline to end of study (8 weeks)
See also
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