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NCT Number: NCT03676686

Study With Nåva Foot Cream in Patients With Tinea Pedis Interdigitalis

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carlanderska sjukhuset, Gothenburg, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Effective clinical treatment rate

    Time frame: 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 outcomes

  1. Frequency of negative fungal culture

    Time frame: Baseline to end of study (8 weeks)

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

  2. Frequency of negative KOH test

    Time frame: Baseline to end of study (8 weeks)

    Frequency of patients with negative KOH test at end of study

  3. Tolerability to the device used

    Time frame: 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

    Time frame: 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

    Time frame: Baseline to end of study (8 weeks)

    Dermatology QoL Index

Sponsors and collaborators

Lead sponsor

Natumin Pharma AB

Industry

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 19, 2018
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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