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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Almirall, S.A.
ClinicalTrials.gov Identifier:
NCT01096472
First received: March 30, 2010
Last updated: July 5, 2012
Last verified: November 2010
  Purpose

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 Intervention Phase
Tinea Pedis
Drug: LAS41003
Drug: LAS189961
Drug: LAS189962
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Almirall, S.A.:

Primary Outcome Measures:
  • Clinical assessment scores and mycological status of fungi (KOH test and mycological culture) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physicians assessment of signs and symptoms (erythema, scaling, vesicles, pustules, crusting, fissuring and maceration) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Percentage of locla skin reactions, AEs

  • Local skin reactions, AEs [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: February 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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);
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096472

Locations
Germany
Investigational Site #2
Berlin, Germany, 10961
Investigational Site #1
Hamburg, Germany, 20095
Sponsors and Collaborators
Almirall, S.A.
Investigators
Study Director: Christoph Willers, MD, MBA Almirall Hermal GmbH
  More Information

No publications provided

Responsible Party: Almirall, S.A.
ClinicalTrials.gov Identifier: NCT01096472     History of Changes
Other Study ID Numbers: H 552 000-0919, 2009-016626-14
Study First Received: March 30, 2010
Last Updated: July 5, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Almirall, S.A.:
Tinea pedis

Additional relevant MeSH terms:
Tinea
Tinea Pedis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Foot Dermatoses
Foot Diseases
Pruritus
Skin Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014