Efficacy Of Sertaconazole 2% (ERTACZO) in the Treatment of Interdigital Tinea Pedis With Once a Day Treatment for 4 Weeks
试验速览
- 阶段
- 3 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 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).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
- •History of atopic or contact dermatitis on the feet.
- •Unstable diabetes mellitus.
- •Subjects who have participated in any previous clinical trial of sertaconazole.
- •Subjects who cannot or will not sign the informed consent.
研究组 & 干预措施
Males and females with athlete's foot
Male and female subjects with athlete's foot inbetween their toes without nail involvement
干预措施: Sertaconazole nitrate cream 2% (Drug)
结局指标
主要结局
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).
时间窗: Baseline visit, 1 week, 2 weeks, 4 weeks, 6 weeks
次要结局
- 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)