An Efficacy Study of a New Formulation of Ketoconazole 2% Cream in Patients With Tinea Pedis, Commonly Known as Athlete's Foot

NCT01110330 | Terminated Phase 3 Results

• 2 other identifiers: CR012910KETFUN3001
• Study Type: interventional
• Target: 583
• Locations: 2 countries
• Sites: 11

Brief Summary

The purpose of this study is to determine if a new formulation of ketoconazole 2% cream is as effective as a current formulation of ketoconazole 2% cream (Nizoral) compared with placebo in treating patients with Tinea pedis, a skin infection commonly known as "athlete's foot" that is caused by a kind of mold called a fungus.

Conditions

Tinea Pedis

Keywords

Tinea Pedis; Ketoconazole (NIZORAL); Antifungal Agents; Miconazole (DAKTARIN)

Outcome Measures

Primary Outcomes (1)

• The Number of Patients in the Positive Baseline Culture Set (PBCS) With Mycological Cure (MC) at Week 6

  Mycological Cure (MC) was defined as having a negative potassium hydroxide (KOH) microscopy and negative fungal culture at Week 6.

  Week 6

Secondary Outcomes (1)

• The Number of Patients in the Positive Baseline Culture Set (PBCS) With Overall Cure (OC) at Week 6

  Week 6

Study Arms (3)

Ketoconazole 2% cream (formulation F126)

EXPERIMENTAL

ketoconazole 2% cream (formulation F126) A topical white homogenous cream containing the equivalent of 20 mg (or 2%) of ketoconazole applied sparingly to all affected areas of the foot (or feet) once daily (at night or in the evenings) for a total of 4 weeks.

Drug: Ketoconazole 2% cream (formulation F126)

Ketoconazole 2% cream (formulation F012) (Nizoral)

EXPERIMENTAL

ketoconazole 2% cream (formulation F012) (Nizoral) A topical white homogenous cream containing the equivalent of 20 mg (or 2%) of ketoconazole identical in appearance to study drug applied sparingly to all affected areas of the foot (or feet) once daily (at night or in the evenings) for a total of 4 weeks.

Drug: Ketoconazole 2% cream (formulation F012) (Nizoral)

Placebo cream

PLACEBO COMPARATOR

Placebo cream A topical white homogenous cream identical in appearance to study drug applied sparingly to all affected areas of the foot (or feet) once daily (at night or in the evenings) for a total of 4 weeks.

Drug: Placebo cream

Interventions

Placebo cream DRUG

A topical, white, homogenous cream identical in appearance to study drug applied sparingly to all affected areas of the foot (or feet), once daily (at night or in the evenings) for a total of 4 weeks.

Placebo cream

Ketoconazole 2% cream (formulation F012) (Nizoral) DRUG

A topical, white, homogenous cream containing the equivalent of 20 mg (or 2%) of ketoconazole identical in appearance to study drug applied sparingly to all affected areas of the foot (or feet), once daily (at night or in the evenings) for a total of 4 weeks.

Ketoconazole 2% cream (formulation F012) (Nizoral)

Ketoconazole 2% cream (formulation F126) DRUG

A topical, white, homogenous cream containing the equivalent of 20 mg (or 2%) of ketoconazole applied sparingly to all affected areas of the foot (or feet), once daily (at night or in the evenings) for a total of 4 weeks.

Ketoconazole 2% cream (formulation F126)

Eligibility Criteria

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

You may qualify if:

• Be co-operative, reliable and sufficiently competent to grade and record symptoms as requested
• have a clinical diagnosis of uncomplicated interdigital Tinea pedis confirmed by KOH microscopy
• Be either post-menopausal or surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry and throughout the study and have a negative urine pregnancy test at screening (applies to women only)
• Sign an informed consent form indicating an understanding of the purpose of and procedures required for the study and willingness to participate in the study

You may not qualify if:

• Have complicated Tinea pedis defined as confluent, diffuse moccasin type tinea pedis of the entire plantar surface (undersurface of foot), onychomycosis (fungal nail infection)
• other dermatomycosis (fungal skin infection) requiring active treatment
• Have a previous sensitivity to imidazole antifungal agents or to any ingredient of the study medication
• Have a history of disallowed therapies including oral (by mouth) antifungal treatments within the previous 6 weeks, recent use (within 2 weeks of the study start) of topical antifungal agent, immunosuppressive or radiation therapy within the previous 4 weeks, recent use (within 2 weeks prior to screening) of other oral antibiotics, systemic corticosteroids or topical corticosteroids or antibiotics applied to the feet
• Be HIV-positive (testing will not be performed)
• Have uncontrolled diabetes mellitus or peripheral vascular disease requiring active treatment

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Study Sites (11)

Unknown Facility

Bydgoszcz, Poland

Location

Unknown Facility

Lodz, Poland

Location

Unknown Facility

Lublin, Poland

Location

Unknown Facility

Torun, Poland

Location

Unknown Facility

Cardiff, United Kingdom

Location

Unknown Facility

Chorley, United Kingdom

Location

Unknown Facility

Glasgow, United Kingdom

Location

Unknown Facility

Liverpool, United Kingdom

Location

Unknown Facility

Manchester, United Kingdom

Location

Unknown Facility

Reading, United Kingdom

Location

Unknown Facility

Sunbury-on-Thames, United Kingdom

Location

MeSH Terms

Conditions

Tinea Pedis

Interventions

Ketoconazole

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

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The study was terminated prematurely by the sponsor due to significant discrepancies between potassium hydroxide and mycological culture results.

Results Point of Contact

• Title: Director Infectious Diseases
• Organization: Jan-Cil Switzerland

41 41 7673477

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2010
• First Posted: April 26, 2010
• Study Start: July 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: April 29, 2014
• Results First Posted: June 6, 2013

Record last verified: 2014-04

Locations

PL (4); GB (7)