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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01096472
Other study ID # H 552 000-0919
Secondary ID 2009-016626-14
Status Completed
Phase Phase 2
First received March 30, 2010
Last updated July 5, 2012
Start date February 2010
Est. completion date June 2010

Study information

Verified date November 2010
Source Almirall, S.A.
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
LAS41003
Once daily
LAS189961
Once daily
LAS189962
Once daily

Locations

Country Name City State
Germany Investigational Site #2 Berlin
Germany Investigational Site #1 Hamburg

Sponsors (1)

Lead Sponsor Collaborator
Almirall, S.A.

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical assessment scores and mycological status of fungi (KOH test and mycological culture) 2 weeks No
Secondary Physicians assessment of signs and symptoms (erythema, scaling, vesicles, pustules, crusting, fissuring and maceration) Percentage of locla skin reactions, AEs 2 weeks No
Secondary Local skin reactions, AEs 2 weeks Yes
See also
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Terminated NCT02842021 - Efficacy and Safety of Product S2G6T-1in Patients With Symptomatic Inflammatory Interdigital Tinea Pedis Phase 2
Completed NCT01712360 - Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis Phase 4
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Completed NCT01519752 - A Therapeutic Equivalence Study of Two Oxiconazole Nitrate Topical Cream Treatments for Patients With Tinea Pedis Phase 1
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Completed NCT01349998 - Safety of a Topical Antifungal Treatment for Tinea Cruris, Tinea Pedis and Tinea Corporis Phase 3
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Completed NCT04265521 - Study With BioCool Footcare in Subjects With Tinea Pedis Interdigitalis and Heel Cracks, Calluses and/or Dry Feet N/A
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Recruiting NCT00856596 - Once a Day Topical Treatment for Athlete's Foot Fungus Inbetween the Toes in Males and Females Phase 3
Completed NCT00869336 - Multicenter Study of the Efficacy and Safety of Luliconazole Cream in Tinea Pedis (Athlete's Foot) Phase 2
Completed NCT00768599 - A Study of Econazole Foam 1% in Athlete's Foot Phase 2
Recruiting NCT00233493 - Spread of Dermatophytes Among Families N/A
Completed NCT03897257 - A Comparison Study of UHE-103 Cream in Subjects With Moccasin Type Tinea Pedis Phase 2
Completed NCT03129321 - Therapeutic Equivalence and Safety of Two Econazole Nitrate Cream, 1% Products in Tinea Pedis Phase 3
Completed NCT02335255 - Evaluate Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® Gel 2% in Tinea Pedis Phase 1