Recruiting
Phase 3

Topical Treatment

Sponsor:

Jamaica Hospital Medical Center

Code:

NCT00856596

Conditions

Tinea Pedis

Athlete's Foot

Foot Fungus

Ringworm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Sertaconazole nitrate cream 2%

Study Details

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

Study ID

NCT00856596

Start date

Mar, 2009

Status verified date

Aug, 2009

Completion date

Sep, 2009

Anticipated

Primary completion date

Aug, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Males and females 18 years of age and over.
2. 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.
3. Subjects must have clinical evidence of interdigital tinea pedis of one or both feet characterized by: moderate erythema and scaling and mild pruritis.
4. 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.
5. Fungal cultures obtained at the baseline visit must be positive by day 14 for the subject to remain in the study.
6. All non-study medications not specifically excluded by this protocol may be continued.
7. All chronic diseases must be stable for at least one month.
8. Acute illnesses must be stabilized before enrollment.
9. 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.

Exclusion Criteria:

1. Under 18 years of age.
2. Pregnant or lactating females.
3. Treatment of sertaconazole or an investigational drug within the last 30 days prior to study enrollment.
4. No medications or emollients or foot powders or treatments other than those used in the study are to be applied to the treatment areas.
5. 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
6. Widespread dermatophytosis: moccasin tinea pedis, onychomycosis, oral, vaginal or chronic mucocutaneous candidiasis, bacterial skin infection.
7. Subject who are known or suspected to be immunocompromised.
8. Known sensitivity to any components of the test medication or hypersensitivity to imidazoles.
9. Any disease or condition that may compromise the evaluation of the therapeutic response of tinea pedis to treatment.
10. History of drug or alcohol dependency in the last 6 months.
11. History of atopic or contact dermatitis on the feet.
12. Unstable diabetes mellitus.
13. Subjects who have participated in any previous clinical trial of sertaconazole.
14. Subjects who cannot or will not sign the informed consent.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Males and females with athlete's foot

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

Interventions

Sertaconazole nitrate cream 2%

Once a day topical cream

Primary outcome measure

  • 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). [ Time Frame: Baseline visit, 1 week, 2 weeks, 4 weeks, 6 weeks ]

Central Contacts and Locations

Central contacts

Locations

Jamaica Hospital Medical Center

Recruiting

Jamaica, New York, United States, 11418

Contacts

Principal Investigator:

Jeffrey Weinberg, MD

More Information

Sponsor

Jamaica Hospital Medical Center

Last update posted

Aug 6, 2009

Last verified

Aug, 2009

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jamaica Hospital Medical Center on 2009-08-06.