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

The dermatophytes are a group of pathogenic fungi that inhabit and invade keratinized tissue
including hair, skin and nails in humans. Infections caused by the three genera of organisms
making up the dermatophytes include: Trichophyton, Microsporum and Epidermophyton.
Infections due to the dermatophytes are termed dermatophytosis or tinea.

Tinea pedis (athlete's foot) is most commonly caused by Trichophyton rubrum, and less
commonly by Trichophyton mentagrophytes and Epidermophyton floccosum.

Tinea infections have been on the rise for variety of reasons including: an aging
population, an increase in immunocompromised individuals, increase use of gyms, swimming
pools, sports activities, wearing of occlusive footwear, and the organisms themselves
becoming more resistant to therapy.

Treatment for tinea pedis usually involves the use of topical therapy with azoles or similar
antifungal agents. The efficacy of the topical agent depends on the duration of therapy,
type of lesion, the mechanism of action of the drug, and the viscosity, hydrophobicity and
acidity of the formulation.

Sertaconazole is a broad spectrum, antifungal agent effective against Candida and
dermatophytes. It has also shown antibacterial and anti-inflammatory activity. Skin
absorption studies have revealed acceptable therapeutic levels of sertaconazole remained in
the skin until 48 hours after application. Half life for drug clearance from the skin is 60
hours. Skin tolerability and phototoxicity studies have revealed sertaconazole to be
effective and safe when compared to other topical antifungal agents.

In 2004 sertaconazole nitrate 2% cream, was FDA approved for the topical treatment of
interdigital tinea pedis in immunocompetent patients 12 years of age and older, caused by
Trichophyton rubrum. Trichophyton mentagrophytes and Epidermophyton floccosum. The approved
dosage is twice a day for a total of four weeks to the affected area. This treatment regimen
may prove to be difficult for many patients to follow and cause a lower cure rate than would
be expected.

It would seem reasonable to postulate that a once a day application would provide adequate
therapeutic levels for interdigital tinea pedis based on several previous findings.
Acceptable therapeutic levels of drug were maintained in the skin after 48 hours of
application and the half-life of the drug is 60 hours. Patient compliance and therefore a
higher mycological cure rate and better clinical outcome should theoretically occur with
once a day dosing of sertaconazole 2%. Once a day dosing should prevent early
discontinuation and better compliance for patients with tinea pedis.

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.