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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. Identifier: NCT01096472
Recruitment Status : Completed
First Posted : March 31, 2010
Last Update Posted : July 9, 2012
Information provided by (Responsible Party):
Almirall, S.A.

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.

Condition or disease Intervention/treatment Phase
Tinea Pedis Drug: LAS41003 Drug: LAS189961 Drug: LAS189962 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2010
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: LAS41003
Once daily
Drug: LAS41003
Once daily

Active Comparator: LAS189962
Once daily
Drug: LAS189962
Once daily

Active Comparator: LAS189961
Once daily
Drug: LAS189961
Once daily

Primary Outcome Measures :
  1. Clinical assessment scores and mycological status of fungi (KOH test and mycological culture) [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. 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. Local skin reactions, AEs [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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);

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01096472

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Investigational Site #2
Berlin, Germany, 10961
Investigational Site #1
Hamburg, Germany, 20095
Sponsors and Collaborators
Almirall, S.A.
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Study Director: Christoph Willers, MD, MBA Almirall Hermal GmbH
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Responsible Party: Almirall, S.A. Identifier: NCT01096472    
Other Study ID Numbers: H 552 000-0919
2009-016626-14 ( EudraCT Number )
First Posted: March 31, 2010    Key Record Dates
Last Update Posted: July 9, 2012
Last Verified: November 2010
Keywords provided by Almirall, S.A.:
Tinea pedis
Additional relevant MeSH terms:
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Tinea Pedis
Skin Diseases, Infectious
Skin Diseases
Foot Dermatoses
Foot Diseases
Skin Manifestations