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

NCT01096472 | Completed Phase 2

• 2 other identifiers: H 552 000-09192009-016626-14
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Tinea Pedis

Keywords

Tinea pedis

Outcome Measures

Primary Outcomes (1)

• Clinical assessment scores and mycological status of fungi (KOH test and mycological culture)

  2 weeks

Secondary Outcomes (2)

• Physicians assessment of signs and symptoms (erythema, scaling, vesicles, pustules, crusting, fissuring and maceration)

  2 weeks

• Local skin reactions, AEs

  2 weeks

Study Arms (3)

LAS41003

EXPERIMENTAL

Once daily

Drug: LAS41003

LAS189962

ACTIVE COMPARATOR

Once daily

Drug: LAS189962

LAS189961

ACTIVE COMPARATOR

Once daily

Drug: LAS189961

Interventions

LAS41003 DRUG

Once daily

LAS41003

LAS189961 DRUG

Once daily

LAS189961

LAS189962 DRUG

Once daily

LAS189962

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Almirall, S.A.: lead

Study Sites (2)

Investigational Site #2

Berlin, 10961, Germany

Location

Investigational Site #1

Hamburg, 20095, Germany

Location

MeSH Terms

Conditions

Tinea Pedis

Interventions

octenidine

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Foot Dermatoses; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pruritus; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christoph Willers, MD, MBA

  Almirall Hermal GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2010
• First Posted: March 31, 2010
• Study Start: February 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 9, 2012

Record last verified: 2010-11

Locations

DE (2)