Study With Nåva Foot Cream in Patients With Tinea Pedis Interdigitalis

Not Applicable

Completed

• Conditions: Tinea Pedis
• Interventions: Device: Nåva Foot Cream

• Registration Number: NCT03676686
• Lead Sponsor: Natumin Pharma AB

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-17
• Study First Submitted QC: 2018-09-17
• Study First Posted: 2018-09-19
• Study Start: 2018-10-01
• Primary Completion: 2019-11-04
• Study Completion: 2019-11-04
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nåva Foot Cream	Nåva Foot Cream	Topical Nåva foot cream administered twice daily.

Primary Outcome Measures

Name	Time	Method
Effective clinical treatment rate	Baseline to end of study (8 weeks)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Univeristetssjukhuset; 🇸🇪 Örebro, Sweden

Carlanderska sjukhuset; 🇸🇪 Göteborg, Sweden

PTC; 🇸🇪 Skövde, Sweden