Study With Nåva Foot Cream in Patients With Tinea Pedis Interdigitalis

NCT03676686 | Completed

• 1 other identifier: Nåva Foot Cream_1
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Frequency of negative fungal culture

  Baseline to end of study (8 weeks)

• Frequency of negative KOH test

  Baseline to end of study (8 weeks)

• Tolerability to the device used

  Baseline to end of study (8 weeks)

• Other clinical signs and symptoms

  Baseline to end of study (8 weeks)

• Dermatology Quality of life

  Baseline to end of study (8 weeks)

Study Arms (1)

Nåva Foot Cream

EXPERIMENTAL

Topical Nåva foot cream administered twice daily.

Device: Nåva Foot Cream

Interventions

Nåva Foot Cream DEVICE

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

Nåva Foot Cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Natumin Pharma AB: lead

Study Sites (3)

Carlanderska sjukhuset

Gothenburg, Sweden

Location

Univeristetssjukhuset

Örebro, Sweden

Location

PTC

Skövde, Sweden

Location

MeSH Terms

Conditions

Tinea Pedis

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Foot Dermatoses; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pruritus; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin Lundvall

  Region Örebro län

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 19, 2018
• Study Start: October 1, 2018
• Primary Completion: November 4, 2019
• Study Completion: November 4, 2019
• Last Updated: February 25, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)