Clinical trial NCT01102387: Efficacy and Safety of LAS41003 in the Treatment of Intertriginous Candida Infections
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Candidiasis
Keywords: Candida infections in intertriginous areas
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
First posted: 2010-04-13
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Clinical efficacy and mycological culture
timeFrame: Day 14
Secondary outcomes:
measure: Physical examination, AEs
timeFrame: 14 Days
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Investigational Site #5
city: Bad Saarow
country: Germany
facility: Investigational Site #4
city: Berlin
country: Germany
facility: Investigational Site #2
city: Dülmen
country: Germany
facility: Investigational Site #6
city: Hamburg
country: Germany
facility: Investigational Site #1
city: Vechta
country: Germany
facility: Investigational Site #3
Study officials:
affiliation: Almirall Hermal GmbH
name: Christoph Willers, MD, MBA
role: STUDY_DIRECTOR
References: