Study With Nåva Foot Cream in Patients With Tinea Pedis Interdigitalis

• Sponsor: Natumin Pharma AB (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03676686
• Collaborator: (none)
• Enrollment: 46
• Locations: 3
• Arm: 1
• Actual Duration (Months): 13.1
• Patients Per Site: 15.3
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tinea Pedis	Device: Nåva Foot Cream	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: Oct 1, 2018
• Actual Primary Completion Date: Nov 4, 2019
• Actual Study Completion Date: Nov 4, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nåva Foot Cream Topical Nåva foot cream administered twice daily.	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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Frequency of negative fungal culture [Baseline to end of study (8 weeks)]

   Frequency of patients with negative fungal culture at end of study.

2. Frequency of negative KOH test [Baseline to end of study (8 weeks)]

   Frequency of patients with negative KOH test at end of study

3. 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)

4. 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)

5. Dermatology Quality of life [Baseline to end of study (8 weeks)]

   Dermatology QoL Index

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Carlanderska sjukhuset	Göteborg		Sweden
2	PTC	Skövde		Sweden
3	Univeristetssjukhuset	Örebro		Sweden

Sponsors and Collaborators

• Natumin Pharma AB

Investigators

• Principal Investigator: Martin Lundvall, Region Örebro Län

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Natumin Pharma AB
• ClinicalTrials.gov Identifier: NCT03676686
• Other Study ID Numbers: Nåva Foot Cream_1
• First Posted: Sep 19, 2018
• Last Update Posted: Feb 25, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Tinea; Tinea Pedis

Study Results

No Results Posted as of Feb 25, 2020