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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01102387
Recruitment Status : Completed
First Posted : April 13, 2010
Last Update Posted : July 4, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Candidiasis Drug: LAS41003 Drug: LAS189962 Drug: LAS189961 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Arm Intervention/treatment
Experimental: LAS41003 Drug: LAS41003
Once daily, topically

Active Comparator: LAS189962 Drug: LAS189962
Once daily, topically

Active Comparator: LAS189961 Drug: LAS189961
Once daily, topically

Primary Outcome Measures :
  1. Clinical efficacy and mycological culture [ Time Frame: Day 14 ]
    Clinical assesment scores and mycological status of candida (mycological culture)

Secondary Outcome Measures :
  1. Physical examination, AEs [ Time Frame: 14 Days ]

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

    Percentage of local skin reactions, AEs

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01102387

Investigational Site #5
Augsburg, Germany, 86179
Investigational Site #4
Bad Saarow, Germany, 15526
Investigational Site #2
Berlin, Germany, 10961
Investigational Site #6
Dülmen, Germany, 48249
Investigational Site #1
Hamburg, Germany, 20095
Investigational Site #3
Vechta, Germany, 49377
Sponsors and Collaborators
Almirall, S.A.
Study Director: Christoph Willers, MD, MBA Almirall Hermal GmbH

Additional Information:
Responsible Party: Almirall, S.A. Identifier: NCT01102387     History of Changes
Other Study ID Numbers: H 552 000 - 0920
2009-016627-56 ( EudraCT Number )
First Posted: April 13, 2010    Key Record Dates
Last Update Posted: July 4, 2012
Last Verified: January 2011

Keywords provided by Almirall, S.A.:
Candida infections in intertriginous areas

Additional relevant MeSH terms: