Study With BioCool Footcare in Subjects With Tinea Pedis Interdigitalis and Heel Cracks, Calluses and/or Dry Feet
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Symptoms of foot fungus [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
- Frequency of negative fungual culture in combination with negative KOH test [Baseline to end of study (3 weeks)]
Frequency of subjects with negative fungual culture in combination with negative KOH test
- Tolerability assessment to BioCool Footcare (foothbath) [Baseline to end of study (3 weeks)]
Tolerability assessed using a 5-point likert scale (very good, good, moderate, poor, very poor)
- Follow-up on heel cracks, calluses and/or dry feet [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)
- Dermatology Quality of Life [Baseline to end of study (3 weeks)]
Dermatology Quality of Life Index
- Adverse Events [Baseline to end of study (3 weeks)]
Adverse Events (AE, ADE, SAE, SADE, USADE)
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Forskningsenheten Carlanderska sjukhuset | Göteborg | Sweden | 40545 | |
| 2 | Avdelningen för klinisk prövning | Örebro | Sweden | 70362 |
Sponsors and Collaborators
- Biocool AB
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BioC001