Efficacy and Safety of LAS41003 in the Treatment of Inflammatory Tinea Pedis

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the efficacy and safety of a topical application of the combinational cream LAS41003 compared to application of its mono-substances after once daily treatment in patients with inflammatory tinea pedis.

Official Title
-----------------
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

Conditions
-----------------
Tinea Pedis

Intervention / Treatment
-----------------
* Drug: LAS41003
* Drug: LAS189961
* Drug: LAS189962


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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; 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; 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 phase and 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);

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LAS41003<br>Once daily | Drug: LAS41003<br>* Once daily<br>|
| Active Comparator: LAS189962<br>Once daily | Drug: LAS189962<br>* Once daily<br>|
| Active Comparator: LAS189961<br>Once daily | Drug: LAS189961<br>* Once daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical assessment scores and mycological status of fungi (KOH test and mycological culture) |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physicians assessment of signs and symptoms (erythema, scaling, vesicles, pustules, crusting, fissuring and maceration) | Percentage of locla skin reactions, AEs | 2 weeks | 
| Local skin reactions, AEs |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tinea pedis