A Phase IIa, two-center, randomized, double-blind study with parallel groups to evaluate the anti-mycotic and anti-inflammatory efficacy of topical combinational product LAS 41003 versus corresponding mono-substances in patients with inflammatory tinea pedis - Tinea pedis

• Conditions: 120 male or female patients with symptomatic moderate to severe tinea pedis will be randomized; MedDRA version: 12.0Level: LLTClassification code 10043873Term: Tinea pedis

• Registration Number: EUCTR2009-016626-14-DE
• Lead Sponsor: Almirall Hermal GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-04
• Last Update Posted: 19 November 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.