NCT00771342已完成2 期
A Blinded Placebo Controlled Single Cross-over Clinical Trial to Evaluate Fungicidal Activity With Topical Application of 1% Gaseous Nitric Oxide in Subjects With Moderate to Severe Tinea Pedis (Athlete's Foot)
Nitric BioTherapeutics, Inc1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2008年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Evidence of fungicidal activity as confirmed by mycological culture or microscopic evaluation and improvement in Clinical Symptom Severity Score
研究概览
简要总结
The purpose of this study is to determine the fungicidal efficacy of nitric oxide and it's effect on the clinical signs and symptoms associated with Tinea Pedis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive clinical findings for moccasin, interdigital or bullous tinea pedis as determined by direct clinical examination
- •Must have a clinical symptom severity score of at least 20 on a possible 64 point scale
- •Written informed consent must be obtained from the subject.
- •Must ≥ 19 years of age
- •Must agree to avoid professional pedicures or application of any nail polish product or nail cosmetic to the toenails after the screening visit until the conclusion of the trial.
- •Must agree to take measures to avoid pregnancy during the 12 day (or 26 day if in cross over group) study period
排除标准
- •Has a diagnosis of either psoriasis or eczema
- •Has a visual diagnosis, by the investigator, of onychomycosis.
- •Use of topical antifungals e.g. (clotrimazole, ketoconazole,miconazole, oxiconazole- (Oxistat®, Glaxo Smith Kline), sulconazole, naftifine (Naftin®, Merz), terconazole, econazole nitrate (Spectazole®, Ortho-McNeil), butoconazole ,Fluconazole, ciclopirox olamine-(Loprox®, Medicis), tolnaftate, haloprogin), Zeasorb-AF , antibacterials and corticosteroids in the preceding 5 days of screening visit (Day 1)
- •Use of systemic corticosteroids in the preceding 7 days of screening visit (Day 1)
- •Use of systemic antifungals in the preceding 7 days of screening visit (Day1) including - (terbinafine - (Lamisil®, Novartis), Itraconazole - (Sporanox®, Janssen), fluconazole- (Diflucan®, Pfizer), ketoconazole, miconazole, griseofulvin (Gris-PEG®, Pedinol), butoconazole, terconazole, Potassium iodide)
- •Has used any investigational drug(s) within 30 days preceding screening visit (Day 1)
- •Has cardiovascular disease, diabetes mellitus, Cushing's Disease, hematological malignancy, chronic mucocutaneous candidiasis or atopy
- •Is pregnant or is a nursing mother
- •Is a woman of child bearing potential who is not using an adequate form of contraception (or abstinence)
- •Is < 19 years of age
- •Suffers from a condition, which, in the opinion of the medical investigator, would compromise his/her safety
研究组 & 干预措施
1
Experimental
1% gasoue nitric oxide, delivered topically for 40 minutes daily for three consecutive days
干预措施: Nitric Oxide (Drug)
2
Placebo Comparator
Nitrogen gas delivered topically for 40 minutes, daily, for 3 consecutive days
干预措施: Nitrogen (Drug)
结局指标
主要结局
Evidence of fungicidal activity as confirmed by mycological culture or microscopic evaluation and improvement in Clinical Symptom Severity Score
时间窗: Day 12 or Day 26
次要结局
- Incidence of adverse events(Duration of the study)
研究者
研究点 (1)
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