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

NCT04265521 | Completed

• 1 other identifier: BioC001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

Foot Fungus; Tinea; Tinea Pedis; Mycoses; Skin Diseases

Outcome Measures

Primary Outcomes (1)

• Symptoms of foot fungus

  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)

  Baseline to end of study (3 weeks)

Secondary Outcomes (5)

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

  Baseline to end of study (3 weeks)

• Tolerability assessment to BioCool Footcare (foothbath)

  Baseline to end of study (3 weeks)

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

  Baseline to end of study (3 weeks)

• Dermatology Quality of Life

  Baseline to end of study (3 weeks)

• Adverse Events

  Baseline to end of study (3 weeks)

Study Arms (1)

Biocool Footcare

EXPERIMENTAL

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

Interventions

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.

Biocool Footcare

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biocool AB: lead

Study Sites (2)

Forskningsenheten Carlanderska sjukhuset

Gothenburg, 40545, Sweden

Location

Avdelningen för klinisk prövning

Örebro, 70362, Sweden

Location

MeSH Terms

Conditions

Tinea; Tinea Pedis; Mycoses; Skin Diseases

Condition Hierarchy (Ancestors)

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

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: February 7, 2020
• First Posted: February 11, 2020
• Study Start: March 3, 2020
• Primary Completion: May 26, 2020
• Study Completion: June 25, 2020
• Last Updated: February 15, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)