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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04265521
Recruitment Status : Recruiting
First Posted : February 11, 2020
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Biocool AB

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Foot Fungus Tinea Tinea Pedis Mycoses Skin Diseases Device: Biocool Footcare Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : June 25, 2020
Estimated Study Completion Date : June 25, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Biocool Footcare

Treatment regime:

During week 1: Once daily for 7 days (7 doses) During week 2 and 3: Once every second day for 14 days (7 doses)

Device: Biocool Footcare
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 Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

  1. Signed informed consent form
  2. > 18 years of age
  3. Males and females
  4. 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.

  5. 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).
  6. Patient with confirmed mycological culture

Exclusion Criteria:

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04265521


Contacts
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Contact: Lisa Welander, VP QA/RA +46704663123 lisa.welander@biocool.se
Contact: Petra von Rohr, CEO +46734390654 petra.vonrohr@biocool.se

Locations
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Sweden
Forskningsenheten Carlanderska sjukhuset Recruiting
Göteborg, Sweden, 40545
Contact: Margareta Sandberg         
Principal Investigator: Kaj Stenlöf, Dr         
Avdelningen för klinisk prövning Recruiting
Örebro, Sweden, 70362
Contact: Lena Irvhage         
Principal Investigator: Martin Lundvall, Dr         
Sponsors and Collaborators
Biocool AB

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Responsible Party: Biocool AB
ClinicalTrials.gov Identifier: NCT04265521    
Other Study ID Numbers: BioC001
First Posted: February 11, 2020    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mycoses
Tinea
Tinea Pedis
Skin Diseases
Dermatomycoses
Skin Diseases, Infectious
Infection
Foot Dermatoses
Foot Diseases
Pruritus
Skin Manifestations
Signs and Symptoms