Once a Day Topical Treatment for Athlete's Foot Fungus Inbetween the Toes in Males and Females

NCT00856596 | Unknown Phase 3 DMC

• 1 other identifier: 08023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The topical cream, Sertaconazole (Ertaczo), has been FDA approved for the treatment of athlete's foot using twice a day dosing for 4 weeks. This study wants to see if sertaconazole will work equally as well with once a day dosing for 4 weeks for athlete's foot.

Conditions

Tinea Pedis; Athlete's Foot; Foot Fungus; Ringworm

Keywords

Tinea pedis; Fungus; Pruritus; Dermatophyte; Athlete's foot; Dermatomycosis; Skin manifestation; Infectious skin disease; Foot diseases

Outcome Measures

Primary Outcomes (1)

• To compare the efficacy and safety of sertaconazole 2% cream applied once a day for four weeks in the treatment of patients with KOH positive and culture positive symptomatic interdigital tinea pedis (athlete's foot).

  Baseline visit, 1 week, 2 weeks, 4 weeks, 6 weeks

Secondary Outcomes (1)

• To compare the time to successful clinical and mycological treatment outcomes for sertaconazole 2% cream applied once a day for four weeks in the treatment of patients with KOH positive and culture positive symptomatic interdigital tinea pedis.

  Baseline visit, 1 week, 2 weeks, 4 weeks, 6 weeks

Study Arms (1)

Males and females with athlete's foot

OTHER

Male and female subjects with athlete's foot inbetween their toes without nail involvement

Drug: Sertaconazole nitrate cream 2%

Interventions

Sertaconazole nitrate cream 2% DRUG

Once a day topical cream

Also known as: Ertaczo cream 2%

Males and females with athlete's foot

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females 18 years of age and over.
• Women of child bearing age must have a negative urine pregnancy test at Day 0 (baseline) and Day 42 (visit 6) or at the discontinuation visit and must agree to use an acceptable method of contraception during the study.
• Subjects must have clinical evidence of interdigital tinea pedis of one or both feet characterized by: moderate erythema and scaling and mild pruritis.
• The clinical diagnosis must be confirmed by a positive KOH preparation, where fungal elements are visible from a skin scraping of the interdigital area of the feet.
• Fungal cultures obtained at the baseline visit must be positive by day 14 for the subject to remain in the study.
• All non-study medications not specifically excluded by this protocol may be continued.
• All chronic diseases must be stable for at least one month.
• Acute illnesses must be stabilized before enrollment.
• The subject must be able to understand what is required, read and sign the informed consent, comply with the requirements of this study and adhere to the visit schedule.

You may not qualify if:

• Under 18 years of age.
• Pregnant or lactating females.
• Treatment of sertaconazole or an investigational drug within the last 30 days prior to study enrollment.
• No medications or emollients or foot powders or treatments other than those used in the study are to be applied to the treatment areas.
• The following medications may not be used during the study:
• Oral anti-fungals 3 months prior to enrollment
• Topical anti-fungals to the feet 14 days prior to enrollment
• Systemic antibiotic or corticosteroid 30 days prior to enrollment
• Topical corticosteroid 30 days prior to enrollment
• Use of radiation therapy and/or anti-neoplastic agents within1 year of enrollment
• Widespread dermatophytosis: moccasin tinea pedis, onychomycosis, oral, vaginal or chronic mucocutaneous candidiasis, bacterial skin infection.
• Subject who are known or suspected to be immunocompromised.
• Known sensitivity to any components of the test medication or hypersensitivity to imidazoles.
• Any disease or condition that may compromise the evaluation of the therapeutic response of tinea pedis to treatment.
• History of drug or alcohol dependency in the last 6 months.

Sponsors & Collaborators

• Jamaica Hospital Medical Center: lead
• Johnson & Johnson: collaborator

Study Sites (1)

Jamaica Hospital Medical Center

Jamaica, New York, 11418, United States

RECRUITING

MeSH Terms

Conditions

Tinea Pedis; Tinea; Pruritus; Dermatomycoses; Skin Manifestations; Skin Diseases, Infectious; Foot Diseases

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Foot Dermatoses; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Musculoskeletal Diseases

Study Officials

• Jeffrey Weinberg, MD

  Jamaica Hospital Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evelyn Koestenblatt

CONTACT

212-523-4511; dermtrial@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 5, 2009
• First Posted: March 6, 2009
• Study Start: March 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: September 1, 2009
• Last Updated: August 6, 2009

Record last verified: 2009-08

Locations

US (1)