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Completed

NCT Number: NCT04265521

Study With BioCool Footcare in Subjects With Tinea Pedis Interdigitalis and Heel Cracks, Calluses and/or Dry Feet

A prospective, open, post-market study that will enroll male and female subjects diagnosed with foot fungus and at least one of the following conditions: heel cracks, calluses and/or dry feet. The investigation will consist of approximately 48 subjects (considering a 10% drop-out/screening failure rate) fulfilling the eligibility criteria for the study. Each subject will be treated with the study product, BioCool Footcare (footbath), for 3 weeks. The study duration is estimated to 5 months including recruiting, treatment and follow-up period.

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Key information

Conditions

Foot Fungus 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 Tinea Pedis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Forskningsenheten 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

The subjects have to meet all of the following criteria to be eligible to participate in the clinical investigation:

  • Signed informed consent form
  • > 18 years of age
  • Males and females
  • Tinea Pedis (Athlete's foot) confirmed with total symptom score graded between 6-16 (erythema, erosions, macerations, pruritus, fissures, burning/stinging, hyperkeratosis and odour) using a 4-point severity scale (0=absent, 1=mild, 2=moderate and 3=severe). NOTE! maximum total score is 24.
  • Score of 2 (moderate) of higher required in at least 1 of the following; erythema, macerations, pruritus or odur.
  • Score of at least 2 (moderate) required in at least one of the following: heel cracks (rhagades), calluses (hyperkeratosis) and dry feet using a 5-point severity scale (0=absent, 1=mild, 2=moderate, 3=advanced and 4=severe).
  • Patient with confirmed mycological culture

Exclusion criteria

Subjects meeting any of the following criteria will not be permitted to participate in the clinical investigation:

  • Severe tinea pedis interdigitalis (Athlete's foot) total score of severity grading >16 (signs and symptoms)
  • Women pregnant or lactation at time of enrolment
  • Diagnosed with Diabetes Type I or II
  • Topical medicinal antifungal therapy within 4 weeks prior to study start
  • Treatment with systemic anti fungal therapy including terbinafine, itraconazole or fluconazole within 6 months prior to study start
  • Treatment with local amd/or systemic corticosteroids or immunosuppressant's within 6 weeks prior to study start
  • Any other open wounds/lesions in the area treated with the Investigational device
  • Participated in another Clinical Investigation/Trial the last 3 months
  • Any other medical condition, judged by the investigator may make follow-up or investigation inappropriate

Treatment and study plan

Biocool Footcare

Device

BioCool Footcare is a footbath containing granulate of sodium percarbonate that will in this study be used for treatment of foot fungus, heel cracks, calluses and/or dry feet.

Primary outcomes

  1. Symptoms of foot fungus

    Time frame: Baseline to end of study (3 weeks)

    Effective treatment rate of the eight clinical signs and symptoms (erythema, erosions, macerations, pruritus, fissures, burning/stinging, hyperkeratosis and odour) using a 4-point severity scale (0=absent, 1=mild, 2=moderate and 3=severe)

Secondary outcomes

  1. Frequency of negative fungual culture in combination with negative KOH test

    Time frame: Baseline to end of study (3 weeks)

    Frequency of subjects with negative fungual culture in combination with negative KOH test

  2. Tolerability assessment to BioCool Footcare (foothbath)

    Time frame: Baseline to end of study (3 weeks)

    Tolerability assessed using a 5-point likert scale (very good, good, moderate, poor, very poor)

  3. Follow-up on heel cracks, calluses and/or dry feet

    Time frame: Baseline to end of study (3 weeks)

    Subject outcome on heel cracks (rhagades), calluses (hyperkeratosis) and/or dry feet using a 5-point scale (0=absent, 1=mild, 2=moderate, 3=advanced, 4=severe)

  4. Dermatology Quality of Life

    Time frame: Baseline to end of study (3 weeks)

    Dermatology Quality of Life Index

  5. Adverse Events

    Time frame: Baseline to end of study (3 weeks)

    Adverse Events (AE, ADE, SAE, SADE, USADE)

Sponsors and collaborators

Lead sponsor

Biocool AB

Industry

Registry information

Official study title

A Prospective Single-arm Investigation to Assess the Efficacy and Safety After Using BioCool Footcare (Footbath) for 3 Weeks of Treatment in Subjects With Mild to Moderate Symptoms/Signs of Tinea Pedis Interdigitalis and Heel Cracks, Calluses and/or Dry Feet.

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 11, 2020
Registry last updated
Feb 15, 2021

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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