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

Phase 2

Completed

• Conditions: Candidiasis
• Interventions: Drug: LAS189962; Drug: LAS189961; Drug: LAS41003

• Registration Number: NCT01102387
• Lead Sponsor: Almirall, S.A.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-03-30
• Study First Submitted QC: 2010-04-12
• Study First Posted: 2010-04-13
• Status Verified: 2011-01
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Last Update Submitted: 2012-07-03
• Last Update Posted: 2012-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LAS189962	LAS189962	-
LAS189961	LAS189961	-
LAS41003	LAS41003	-

Primary Outcome Measures

Name	Time	Method
Clinical efficacy and mycological culture	Day 14	Clinical assesment scores and mycological status of candida (mycological culture)

Secondary Outcome Measures

Name	Time	Method
Physical examination, AEs	14 Days	Physician assesmentes of sign and symptoms (erythema, papules, pustules and maceration); Percentage of local skin reactions, AEs

Trial Locations

Locations (6)

Investigational Site #5; 🇩🇪 Augsburg, Germany

Investigational Site #2; 🇩🇪 Berlin, Germany

Investigational Site #4; 🇩🇪 Bad Saarow, Germany

Investigational Site #6; 🇩🇪 Dülmen, Germany

Investigational Site #3; 🇩🇪 Vechta, Germany

Investigational Site #1; 🇩🇪 Hamburg, Germany