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

Almirall, S.A.2 sites in 1 country120 target enrollmentFebruary 2010

ConditionsTinea Pedis

InterventionsLAS41003 LAS189962 LAS189961

DrugsLAS41003 LAS189961 LAS189962

Overview

Phase: Phase 2
Intervention: LAS41003
Conditions: Tinea Pedis
Sponsor: Almirall, S.A.
Enrollment: 120
Locations: 2
Primary Endpoint: Clinical assessment scores and mycological status of fungi (KOH test and mycological culture)
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2010

End Date

June 2010

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Almirall, S.A.

Responsible Party

Sponsor

Eligibility Criteria

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;

Arms & Interventions

LAS41003

Once daily

Intervention: LAS41003

LAS189962

Once daily

Intervention: LAS189962

LAS189961

Once daily

Intervention: LAS189961

Outcomes

Primary Outcomes

Clinical assessment scores and mycological status of fungi (KOH test and mycological culture)

Time Frame: 2 weeks

Secondary Outcomes

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