Clinical trial NCT01096472: Efficacy and Safety of LAS41003 in the Treatment of Inflammatory Tinea Pedis
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tinea Pedis
Keywords: Tinea pedis
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
First posted: 2010-03-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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;
* 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);

Primary outcomes:
measure: Clinical assessment scores and mycological status of fungi (KOH test and mycological culture)
timeFrame: 2 weeks
Secondary outcomes:
measure: Physicians assessment of signs and symptoms (erythema, scaling, vesicles, pustules, crusting, fissuring and maceration)
timeFrame: 2 weeks
measure: Local skin reactions, AEs
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Investigational Site #2
city: Hamburg
country: Germany
facility: Investigational Site #1
Study officials:
affiliation: Almirall Hermal GmbH
name: Christoph Willers, MD, MBA
role: STUDY_DIRECTOR
References: