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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
  Purpose

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 Intervention Phase
Candidiasis
Drug: LAS41003
Drug: LAS189962
Drug: LAS189961
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Almirall, S.A.:

Primary Outcome Measures:
  • Clinical efficacy and mycological culture [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    Clinical assesment scores and mycological status of candida (mycological culture)


Secondary Outcome Measures:
  • 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



Enrollment: 137
Study Start Date: February 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LAS41003 Drug: LAS41003
Once daily, topically
Active Comparator: LAS189962 Drug: LAS189962
Once daily, topically
Active Comparator: LAS189961 Drug: LAS189961
Once daily, topically

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01102387

Locations
Germany
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.
Investigators
Study Director: Christoph Willers, MD, MBA Almirall Hermal GmbH
  More Information

Additional Information:
No publications provided

Responsible Party: Almirall, S.A.
ClinicalTrials.gov Identifier: NCT01102387     History of Changes
Other Study ID Numbers: H 552 000 - 0920, 2009-016627-56
Study First Received: March 30, 2010
Last Updated: July 3, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Candidiasis
Infection
Mycoses

ClinicalTrials.gov processed this record on November 27, 2014