Efficacy and Safety of LAS41003 in the Treatment of Inflammatory Tinea Pedis
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
Study Start Date
Primary Completion Date
Study Completion Date
Resource links provided by the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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);