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

Tinea Pedis Clinical Trial

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

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

• Tinea
• Tinea Pedis

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