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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Almirall, S.A.

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;

• 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);