Tinea pedis
Conditions
Interventions
Each subject will administer a single dose (thin layer) of either the treatment
cream or placebo cream twice daily for four weeks and spray the shoes with
either active or placebo spray, according t
Sponsors
Medical Brands B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adults (18 years or older), tinea pedis clinically and microscopically confirmed, mild to moderate infection
Exclusion criteria
Exclusion criteria: Pregnancy, onychomycosis at (adjacent) toes, diabetes, immunosuppresive diseases, usage of other anti-fungal medication or treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy The first primary objective is to determine the clinical efficacy of the Athlete*s Foot Kit in treating mild to moderate tinea pedis, also known as athlete*s foot on the skin of the feet. Aim is to reduce clinical signs and symptoms (clinical assessment) to a level where athlete*s foot is considered to be absent. Success rate in the treatment group is expected to be significantly higher when compared to placebo. The case report form (CRF) is used to document the results. Pictures are taken at each visit to make the effect visible and to keep track on occurence of (adverse) effects on the skin. Safety and tolerability The second primary objective is to evaluate the safety and tolerability of the Athlete*s Foot Kit. Adverse Events (AEs) and Adverse Device Effects (ADEs; adverse events due to the use of investigational product) are documented in both treatment and placebo group and compared qualitatively and quantitatively. Amount and severeness of AEs/ADEs should not differ between the groups. Based upon the efficacy trial as performed by Medical Brands (2010) and post-market surveillance data, AEs/ADEs are expected to be infrequent and non-severe. The subject diary and the case report form are used to make sure subjects are asked frequently for unforeseen and/or AEs/ADEs and to document them. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of mycologic cure To verify the eradication of the fungal infection, which is primary assessed by the clinician by signs and symptoms, mycologic cure is determined by KOH staining. Results are linked with the results of clinical evaluation per subject; results should correlate. Study arms are compared. Evaluation of overall consumer satisfaction A Subject Diary, a Subject*s Global Impression of Improvement Questionnaire and an Itch Questionnaire are used to determine overall satisfaction with the product (pen and spray), as judged by the user, to determine immediate relief of itch after product application and to determine overall improvement itch at the end of treatment. Results of both study arms are compared. Evaluation of overall clinician satisfaction A Clinician*s Global Impression of Improvement Questionnaire is included in the CRF to determine overall satisfaction with the product (pen and spray), as judged by the clinician. Results of both study arms are compared. Compliance to study procedure To determine subject*s compliance to the treatment procedure, subject diary reminds subjects on a daily basis and asks subjects if treatment was applied. Compliance should not differ between groups. | — |
Countries
Netherlands
Outcome results
None listed