- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01096472
Efficacy and Safety of LAS41003 in the Treatment of Inflammatory Tinea Pedis
July 5, 2012 updated by: Almirall, S.A.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Berlin, Germany, 10961
- Investigational Site #2
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Hamburg, Germany, 20095
- Investigational Site #1
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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);
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: LAS41003
Once daily
|
Once daily
|
ACTIVE_COMPARATOR: LAS189962
Once daily
|
Once daily
|
ACTIVE_COMPARATOR: LAS189961
Once daily
|
Once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical assessment scores and mycological status of fungi (KOH test and mycological culture)
Time Frame: 2 weeks
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physicians assessment of signs and symptoms (erythema, scaling, vesicles, pustules, crusting, fissuring and maceration)
Time Frame: 2 weeks
|
Percentage of locla skin reactions, AEs
|
2 weeks
|
Local skin reactions, AEs
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (ACTUAL)
June 1, 2010
Study Completion (ACTUAL)
June 1, 2010
Study Registration Dates
First Submitted
March 30, 2010
First Submitted That Met QC Criteria
March 30, 2010
First Posted (ESTIMATE)
March 31, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
July 9, 2012
Last Update Submitted That Met QC Criteria
July 5, 2012
Last Verified
November 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H 552 000-0919
- 2009-016626-14 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tinea Pedis
-
National institute of SiddhaCompletedTinea Infections Such as Tinea Corporis, Tinea Cruris, Tinea Pedis, Tinea Mannum, Tinea Barbae, Tinea Capitis Are StudiedIndia
-
Taro Pharmaceuticals USATerminated
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DermBiont, Inc.TerminatedInterdigital Tinea PedisDominican Republic
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AmDermaAmDerma Pharmaceuticals, LLCCompletedInterdigital Tinea PedisUnited States
-
Ahmed A. H. AbdellatifUnknownFoot Infection Tinea PedisEgypt
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NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences...CompletedOnychomycosis/Onycholysis and Tinea PedisUnited States
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Tinea PharmaceuticalsCompletedTinea Pedis | Tinea Cruris | Tinea CorporisUnited States, Puerto Rico, El Salvador, Belize, Honduras
-
Therapeutics, Inc.RecruitingTinea Pedis | Tinea CrurisUnited States
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Bausch & Lomb IncorporatedBausch Health Americas, Inc.CompletedTinea Pedis | Tinea CrurisUnited States
-
Bausch Health Americas, Inc.CompletedTinea Pedis | Tinea CrurisDominican Republic, Honduras
Clinical Trials on LAS41003
-
Almirall, S.A.Completed
-
Almirall, S.A.Completed