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

March 30, 2010
July 3, 2012
February 2010
July 2011   (final data collection date for primary outcome measure)
Clinical efficacy and mycological culture [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
Clinical assesment scores and mycological status of candida (mycological culture)
Same as current
Complete list of historical versions of study NCT01102387 on ClinicalTrials.gov Archive Site
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

Same as current
Not Provided
Not Provided
 
Efficacy and Safety of LAS41003 in the Treatment of Intertriginous Candida Infections
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Candidiasis
  • Drug: LAS41003
    Once daily, topically
  • Drug: LAS189962
    Once daily, topically
  • Drug: LAS189961
    Once daily, topically
  • Experimental: LAS41003
    Intervention: Drug: LAS41003
  • Active Comparator: LAS189962
    Intervention: Drug: LAS189962
  • Active Comparator: LAS189961
    Intervention: Drug: LAS189961
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
137
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01102387
H 552 000 - 0920, 2009-016627-56
No
Almirall, S.A.
Almirall, S.A.
Not Provided
Study Director: Christoph Willers, MD, MBA Almirall Hermal GmbH
Almirall, S.A.
January 2011

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