Efficacy and Safety of LAS41003 in the Treatment of Intertriginous Candida Infections

Candidiasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01102387
• Other study ID #: H 552 000 - 0920
• Secondary ID: 2009-016627-56
• Status: Completed
• Phase: Phase 2
• First received: March 30, 2010
• Last updated: July 3, 2012
• Start date: February 2010
• Est. completion date: July 2011

Study information

• Verified date: January 2011
• Source: Almirall, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidiasis

Intervention

Drug:
• LAS41003
Once daily, topically
• LAS189962
Once daily, topically
• LAS189961
Once daily, topically

Locations

Country	Name	City	State
Germany	Investigational Site #5	Augsburg
Germany	Investigational Site #4	Bad Saarow
Germany	Investigational Site #2	Berlin
Germany	Investigational Site #6	Dülmen
Germany	Investigational Site #1	Hamburg
Germany	Investigational Site #3	Vechta

Sponsors (1)

Lead Sponsor	Collaborator
Almirall, S.A.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical efficacy and mycological culture	Clinical assesment scores and mycological status of candida (mycological culture)	Day 14	No
Secondary	Physical examination, AEs	Physician assesmentes of sign and symptoms (erythema, papules, pustules and maceration); Percentage of local skin reactions, AEs	14 Days	Yes

External Links

•   Almirall Corporate Website