Efficacy and Safety of LAS41003 in the Treatment of Inflammatory Tinea Pedis

July 5, 2012 updated by: Almirall, S.A.

Phase IIa, Two-center, Randomized, Double Blind Study With Parallel Groups to Evaluate the Anti-mycotic and Anti-inflammatory Efficacy of Topical Combinational Product LAS 41003 Versus Corresponding Mono-substances in Patients With Inflammatory Tinea Pedis

The aim of this study is to determine the efficacy and safety of a topical application of the combinational cream LAS41003 compared to application of its mono-substances after once daily treatment in patients with inflammatory tinea pedis.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Berlin, Germany, 10961
        • Investigational Site #2
      • Hamburg, Germany, 20095
        • Investigational Site #1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 tinea pedis caused by dermatophytes on one or both feet, characterized by physician's global assessment score of 2 ("notable signs and symptoms exist") or 3 ("prominent signs and symptoms exist") at baseline;
  • the physical examination must be without other disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study;
  • 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;
  • patients must be willing and able to comply with the requirements of the trial protocol;
  • written informed consent obtained.

Exclusion Criteria:

  • patients with hyperkeratotic chronic plantar tinea pedis (moccasin type);
  • receiving systemic therapy with cytotoxic or immunosuppressive drugs either concurrently or within 12 weeks before the baseline visit;
  • oral antifungal therapies within three months before study entry (8 months for oral terbinafine), systemic antibiotic or corticosteroid treatment, topical corticosteroids within 30 days before study entry;
  • patients with diabetes;
  • patients with compromised circulation;
  • 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 the treatment phase and during the study;
  • participation in the treatment phase of another clinical study within the last four weeks prior to the first administration of investigational drug in this 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 treatment phase of the study (e.g. glucocorticosteroids);

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: LAS41003
Once daily
Once daily
ACTIVE_COMPARATOR: LAS189962
Once daily
Once daily
ACTIVE_COMPARATOR: LAS189961
Once daily
Once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical assessment scores and mycological status of fungi (KOH test and mycological culture)
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physicians assessment of signs and symptoms (erythema, scaling, vesicles, pustules, crusting, fissuring and maceration)
Time Frame: 2 weeks
Percentage of locla skin reactions, AEs
2 weeks
Local skin reactions, AEs
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (ACTUAL)

June 1, 2010

Study Completion (ACTUAL)

June 1, 2010

Study Registration Dates

First Submitted

March 30, 2010

First Submitted That Met QC Criteria

March 30, 2010

First Posted (ESTIMATE)

March 31, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 9, 2012

Last Update Submitted That Met QC Criteria

July 5, 2012

Last Verified

November 1, 2010

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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