Efficacy and Safety of LAS41003 in the Treatment of Intertriginous Candida Infections

Study Overview
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Brief Summary
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The aim of this study is to determine the efficacy and safety of once daily topical application of the combinational cream LAS41003 compared to the corresponding mono-substances in the treatment of candida infections in intertriginous areas at the trunk.

Official Title
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Phase IIa, Two-centre, Randomized, Double Blind Study to Evaluate the Anti-mycotic and Anti-inflammatory Efficacy of Topical Combinational Product LAS41003 Versus Corresponding Mono-substances in Patients With Candida Infections in Intertriginous Areas at the Trunk

Conditions
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Candidiasis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: presence of candida infections in one or more intertriginous areas (trunk), confirmed by positive mycological sample at baseline; 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; written informed consent Exclusion Criteria: receiving systemic therapy with cytotoxic or immunosuppressive drugs either concurrently or within 12 weeks before the baseline visit; patients who have been treated with oral anti-fungal agents within the 12 weeks prior to study entry or treated with topical anti-fungal agents on the intertrigines within the previous 2 weeks; 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 and during the study; treatment with any other investigational drug in the four weeks preceding the 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 beginning of the study (e.g. glucocorticosteroids); in the opinion of the investigator or physician performing the initial examination the subject should not participate in the study, e.g. due to probable non-compliance or inability to

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical efficacy and mycological culture | Clinical assesment scores and mycological status of candida (mycological culture) | Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical examination, AEs | Physician assesmentes of sign and symptoms (erythema, papules, pustules and maceration) Percentage of local skin reactions, AEs | 14 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Candida infections in intertriginous areas