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
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
Mycoses

ClinicalTrials.gov processed this record on April 17, 2014