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

Phase 2

Completed

• Conditions: Tinea Pedis
• Interventions: Drug: LAS41003; Drug: LAS189962; Drug: LAS189961

• Registration Number: NCT01096472
• Lead Sponsor: Almirall, S.A.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-03-30
• Study First Submitted QC: 2010-03-30
• Study First Posted: 2010-03-31
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2010-11
• Last Update Submitted: 2012-07-05
• Last Update Posted: 2012-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

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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);

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LAS41003	LAS41003	Once daily
LAS189962	LAS189962	Once daily
LAS189961	LAS189961	Once daily

Primary Outcome Measures

Name	Time	Method
Clinical assessment scores and mycological status of fungi (KOH test and mycological culture)	2 weeks

Secondary Outcome Measures

Name	Time	Method
Physicians assessment of signs and symptoms (erythema, scaling, vesicles, pustules, crusting, fissuring and maceration)	2 weeks	Percentage of locla skin reactions, AEs
Local skin reactions, AEs	2 weeks

Trial Locations

Locations (2)

Investigational Site #2; 🇩🇪 Berlin, Germany

Investigational Site #1; 🇩🇪 Hamburg, Germany