120 male or female patients with symptomatic moderate to severe tinea pedis will be randomized MedDRA version: 12.0 Level: LLT Classification code 10043873 Term: Tinea pedis
Conditions
Sponsors
Almirall Hermal GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of the following criteria have to be met for inclusion of a patient in the study: • men and women aged 18 years or over; • presence of tinea pedis caused by dermatophytes on one or both feet, characterized by physician’s global assessment score of 2 (“notable signs and symptoms exist”) or 3 (“prominent signs and symptoms exist”) at baseline; • the physical examination must be without other disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study; • female volunteers of childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1 % per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices [IUDs], sexual abstinence or vasectomized partner; • patients must be willing and able to comply with the requirements of the trial protocol; • written informed consent obtained. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients are to be excluded from the study when one or more of the following conditions are met: • patients with hyperkeratotic chronic plantar tinea pedis (moccasin type); • receiving systemic therapy with cytotoxic or immunosuppressive drugs either concurrently or within 12 weeks before the baseline visit; • received treatments like foot or shoe powders, pharmaceutical and cosmetic topicals (e.g. creams/gels, except for washing products) or topical anti-fungal therapy of the feet within 30 days before study entry; • oral antifungal therapies within three months before study entry (8 months for oral terbinafine), systemic antibiotic or corticosteroid treatment, topical corticosteroids within 30 days before study entry; • radiation therapy and/or anti-neoplastic agents within one year before study entry; • receiving potassium permanganate drugs either concurrently or within 1 week before the baseline visit; • patients with diabetes; • patients with compromised circulation; • evidence of drug or alcohol abuse; • pregnancy or nursing; • symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before the treatment phaseand during the study; • participation in the treatment phase of another clinical study within the last four weeks prior to the first administration of investigational drug in this study; • known allergic reactions to components of the study preparations, hypersensitivity against cetylstearyl alcohol; • treatment with systemic or locally acting medications which might counter or influence the study aim within two weeks before the treatment phase of the study (e.g. glucocorticosteroids); • in the opinion of the investigator or physician performing the initial examination the patient should not participate in the study, e.g. due to probable non-compliance or inability to understand the study and give adequately informed consent; • patient is institutionalized because of legal or regulatory order.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of a combined octenidine/prednicarbate cream in comparison to creams with prednicarbate or octenidine alone after once daily treatment over a 2-week period in patients with inflammatory tinea pedis;Secondary Objective: n.a.;Primary end point(s): Treatment success is the primary endpoint for this explorative study. | — |
Countries
Germany
Outcome results
None listed