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Study With Nåva Foot Cream in Patients With Tinea Pedis Interdigitalis

Primary Purpose

Tinea Pedis

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Nåva Foot Cream
Sponsored by
Natumin Pharma AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinea Pedis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Carlanderska sjukhuset
  • PTC
  • Univeristetssjukhuset

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nåva Foot Cream

Arm Description

Topical Nåva foot cream administered twice daily.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 17, 2018
Last Updated
February 24, 2020
Sponsor
Natumin Pharma AB
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1. Study Identification

Unique Protocol Identification Number
NCT03676686
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
November 4, 2019 (Actual)
Study Completion Date
November 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Natumin Pharma AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinea Pedis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nåva Foot Cream
Arm Type
Experimental
Arm Description
Topical Nåva foot cream administered twice daily.
Intervention Type
Device
Intervention Name(s)
Nåva Foot Cream
Intervention Description
Nåva Foot Cream is a Medical device (EU class IIa) for the treatment of tinea pedis, heal cracks, calluses and dry feet.
Primary Outcome Measure Information:
Title
Effective clinical treatment rate
Description
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.
Time Frame
Baseline to end of study (8 weeks)
Secondary Outcome Measure Information:
Title
Frequency of negative fungal culture
Description
Frequency of patients with negative fungal culture at end of study.
Time Frame
Baseline to end of study (8 weeks)
Title
Frequency of negative KOH test
Description
Frequency of patients with negative KOH test at end of study
Time Frame
Baseline to end of study (8 weeks)
Title
Tolerability to the device used
Description
Tolerability assessed using a 5-point Likert scale (very good, good, moderate, poor, and very poor)
Time Frame
Baseline to end of study (8 weeks)
Title
Other clinical signs and symptoms
Description
• Long term follow-up (8 weeks) on patient outcomes on heel cracks(rhagades), calluses and/or dry feet (hyperkeratosis)
Time Frame
Baseline to end of study (8 weeks)
Title
Dermatology Quality of life
Description
Dermatology QoL Index
Time Frame
Baseline to end of study (8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed Informed Consent Form > 18 years of age Tinea pedis (Athlete's foot) confirmed with positive mycological culture for a dermatophyte 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 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: Patients with negative mycological culture Severe tinea pedis interdigitalis (Athlete's foot) total score of grading sign and symptoms > 16 Women pregnant or lactation at time of enrolment Patients using medicinal topical antifungal therapy within 4 weeks prior to study start Treatment with oral terbinafine, itraconazole or fluconazole within 6 months prior to start of study Treatment with other systemic antifungals within 12 weeks prior to start of study Treatment with systemic corticosteroids or immunosuppressants within 6 weeks prior to start of study Any other condition that as judged by the investigator may make follow-up or investigations inappropriate Any patient that according to the Declaration of Helsinki is unsuitable for enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Lundvall
Organizational Affiliation
Region Örebro Län
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carlanderska sjukhuset
City
Göteborg
Country
Sweden
Facility Name
PTC
City
Skövde
Country
Sweden
Facility Name
Univeristetssjukhuset
City
Örebro
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study With Nåva Foot Cream in Patients With Tinea Pedis Interdigitalis

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