Study With Nåva Foot Cream in Patients With Tinea Pedis Interdigitalis

NCT ID: NCT03676686

Last Updated: 2020-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2019-11-04

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.

Conditions

Tinea Pedis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nåva Foot Cream

Topical Nåva foot cream administered twice daily.

Group Type: EXPERIMENTAL

Nåva Foot Cream

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Natumin Pharma AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Lundvall

Role: PRINCIPAL_INVESTIGATOR

Region Örebro Län

Locations

Carlanderska sjukhuset

Gothenburg, , Sweden

Univeristetssjukhuset

Örebro, , Sweden

PTC

Skövde, , Sweden

Countries

Sweden

Other Identifiers

Nåva Foot Cream_1

Identifier Type: -

Identifier Source: org_study_id