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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Almirall, S.A.

ClinicalTrials.gov Identifier:

NCT01102387

First received: March 30, 2010

Last updated: July 3, 2012

Last verified: January 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 30, 2010

Last Updated Date

July 3, 2012

Start Date ^ICMJE

February 2010

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Clinical efficacy and mycological culture [ Time Frame: Day 14 ] [ Designated as safety issue: No ]

Clinical assesment scores and mycological status of candida (mycological culture)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01102387 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Physical examination, AEs [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]

Physician assesmentes of sign and symptoms (erythema, papules, pustules and maceration)

Percentage of local skin reactions, AEs

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Candidiasis

Intervention ^ICMJE

Drug: LAS41003
Once daily, topically
Drug: LAS189962
Once daily, topically
Drug: LAS189961
Once daily, topically

Study Arm (s)

Experimental: LAS41003
Intervention: Drug: LAS41003
Active Comparator: LAS189962
Intervention: Drug: LAS189962
Active Comparator: LAS189961
Intervention: Drug: LAS189961

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

137

Completion Date

July 2011

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01102387

Other Study ID Numbers ^ICMJE

H 552 000 - 0920, 2009-016627-56

Has Data Monitoring Committee

Responsible Party

Almirall, S.A.

Study Sponsor ^ICMJE

Almirall, S.A.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Christoph Willers, MD, MBA

Almirall Hermal GmbH

Information Provided By

Almirall, S.A.

Verification Date

January 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top