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

Almirall, S.A.6 sites in 1 country137 target enrollmentFebruary 2010

ConditionsCandidiasis

InterventionsLAS41003 LAS189962 LAS189961

DrugsLAS41003 LAS189962 LAS189961

Overview

Phase: Phase 2
Intervention: LAS41003
Conditions: Candidiasis
Sponsor: Almirall, S.A.
Enrollment: 137
Locations: 6
Primary Endpoint: Clinical efficacy and mycological culture
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2010

End Date

July 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Almirall, S.A.

Responsible Party

Sponsor

Eligibility Criteria

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