Study With Nåva Foot Cream in Patients With Tinea Pedis Interdigitalis

Tinea Pedis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03676686
• Other study ID #: Nåva Foot Cream_1
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Tinea
• Tinea Pedis

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)