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.

Study Overview

• Status: Completed
• Conditions: Candidiasis
• Intervention / Treatment: Drug: LAS41003; Drug: LAS189962; Drug: LAS189961

• Study Type: Interventional
• Enrollment (Actual): 137
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Augsburg, Germany, 86179
    • Investigational Site #5
  • Bad Saarow, Germany, 15526
    • Investigational Site #4
  • Berlin, Germany, 10961
    • Investigational Site #2
  • Dülmen, Germany, 48249
    • Investigational Site #6
  • Hamburg, Germany, 20095
    • Investigational Site #1
  • Vechta, Germany, 49377
    • Investigational Site #3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical efficacy and mycological culture	Clinical assesment scores and mycological status of candida (mycological culture)	Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical examination, AEs	Physician assesmentes of sign and symptoms (erythema, papules, pustules and maceration) Percentage of local skin reactions, AEs	14 Days

Collaborators and Investigators

• Sponsor: Almirall, S.A.

Publications and helpful links

Helpful Links

• Almirall Corporate Website

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: March 30, 2010
• First Submitted That Met QC Criteria: April 12, 2010
• First Posted (Estimate): April 13, 2010

Study Record Updates

• Last Update Posted (Estimate): July 4, 2012
• Last Update Submitted That Met QC Criteria: July 3, 2012
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: Candida infections in intertriginous areas
• Additional Relevant MeSH Terms: Bacterial Infections and Mycoses; Mycoses; Infections; Candidiasis; Anti-Infective Agents, Local; Anti-Infective Agents; Octenidine
• Other Study ID Numbers: H 552 000 - 0920; 2009-016627-56 (EudraCT Number)