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

NCT ID: NCT01102387

Last Updated: 2012-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-07-31

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.

Detailed Description

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Conditions

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Candidiasis

Keywords

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Candida infections in intertriginous areas

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LAS41003

Group Type EXPERIMENTAL

LAS41003

Intervention Type DRUG

Once daily, topically

LAS189962

Group Type ACTIVE_COMPARATOR

LAS189962

Intervention Type DRUG

Once daily, topically

LAS189961

Group Type ACTIVE_COMPARATOR

LAS189961

Intervention Type DRUG

Once daily, topically

Interventions

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LAS41003

Once daily, topically

Intervention Type DRUG

LAS189962

Once daily, topically

Intervention Type DRUG

LAS189961

Once daily, topically

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Almirall, S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christoph Willers, MD, MBA

Role: STUDY_DIRECTOR

Almirall Hermal GmbH

Locations

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Investigational Site #5

Augsburg, , Germany

Site Status

Investigational Site #4

Bad Saarow, , Germany

Site Status

Investigational Site #2

Berlin, , Germany

Site Status

Investigational Site #6

Dülmen, , Germany

Site Status

Investigational Site #1

Hamburg, , Germany

Site Status

Investigational Site #3

Vechta, , Germany

Site Status

Countries

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Germany

Related Links

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http://www.almirall.com/webcorp2/cda/ImD_04_02.jsp

Almirall Corporate Website

Other Identifiers

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2009-016627-56

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

H 552 000 - 0920

Identifier Type: -

Identifier Source: org_study_id