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

NCT01102387 | Completed Phase 2

• 2 other identifiers: H 552 000 - 09202009-016627-56
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 6

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.

Conditions

Candidiasis

Keywords

Candida infections in intertriginous areas

Outcome Measures

Primary Outcomes (1)

• Clinical efficacy and mycological culture

  Clinical assesment scores and mycological status of candida (mycological culture)

  Day 14

Secondary Outcomes (1)

• Physical examination, AEs

  14 Days

Study Arms (3)

LAS41003

EXPERIMENTAL

Drug: LAS41003

LAS189962

ACTIVE COMPARATOR

Drug: LAS189962

LAS189961

ACTIVE COMPARATOR

Drug: LAS189961

Interventions

LAS41003 DRUG

Once daily, topically

LAS41003

LAS189962 DRUG

Once daily, topically

LAS189962

LAS189961 DRUG

Once daily, topically

LAS189961

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Almirall, S.A.: lead

Study Sites (6)

Investigational Site #5

Augsburg, 86179, Germany

Location

Investigational Site #4

Bad Saarow, 15526, Germany

Location

Investigational Site #2

Berlin, 10961, Germany

Location

Investigational Site #6

Dülmen, 48249, Germany

Location

Investigational Site #1

Hamburg, 20095, Germany

Location

Investigational Site #3

Vechta, 49377, Germany

Location

Related Links

• Almirall Corporate Website

MeSH Terms

Conditions

Candidiasis

Interventions

octenidine

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Study Officials

• Christoph Willers, MD, MBA

  Almirall Hermal GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2010
• First Posted: April 13, 2010
• Study Start: February 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 4, 2012

Record last verified: 2011-01

Locations

DE (6)