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

Almirall

Status and phase: Completed; Phase 2

Conditions: Tinea Pedis

Treatments: Drug: LAS41003; Drug: LAS189962; Drug: LAS189961

Study type: Interventional

Funder types: Industry

Identifiers

NCT01096472

2009-016626-14 (EudraCT Number)

H 552 000-0919

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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);

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups

LAS41003

Experimental group

Description:

Once daily

Treatment:

Drug: LAS41003

LAS189962

Active Comparator group

Description:

Once daily

Treatment:

Drug: LAS189962

LAS189961

Active Comparator group

Description:

Once daily

Treatment:

Drug: LAS189961