A Blinded Placebo Controlled Clinical Trial To Evaluate Fungicidal Activity With The Topical Application Of Nitric Oxide Releasing Solution (Nors) In Subjects With Moderate To Severe Tinea Pedis (Athlete's Foot)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of Participants With Complete Cure: Post Treatment (Day 31)
研究概览
简要总结
The purpose of this study is to determine the fungicidal efficacy of nitric oxide releasing solution footbath and it's effect on the clinical signs and symptoms associated with Tinea Pedis
详细描述
Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Sequential Assignment Masking: Double Blind (Subject & Assessor) Primary Purpose: Treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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, for study sites located in British Columbia. For other locations the subject must be ≥ 18 years of age, unless local laws dictate otherwise.
- •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 31 day study period
排除标准
- •Has a diagnosis of either psoriasis or eczema, in or immediately around the area under evaluation.
- •Has a visual diagnosis, by the investigator, of onychomycosis at a level, which in the opinion of the investigator could compromise the integrity of the study.
- •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®), tolnaftate, haloprogin), Zeasorb, antibacterials and corticosteroids in the preceding 5 days of screening visit (Day 1) on or immediately around the area under evaluation.
- •Use of systemic corticosteroids in the preceding 7 days respectively, 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 (GrisPEG®), butoconazole, terconazole, Potassium iodide)
- •Has used any investigational drug(s) within 30 days preceding screening visit (Day 1)
- •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, for study sites located in British Columbia. For other locations subject is < 18 years of age, unless local laws dictate otherwise.
- •Suffers from a condition, which, in the opinion of the medical investigator, would compromise his/her safety and / or the quality of the data. Such conditions may include collagen vascular disease, diabetes mellitus, Cushing's Disease, hematological malignancy, chronic mucocutaneous candidiasis or atopy
研究组 & 干预措施
Control
Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days.
干预措施: Water (Drug)
Nitric oxide
Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days.
干预措施: Nitric Oxide (Drug)
结局指标
主要结局
Number of Participants With Complete Cure: Post Treatment (Day 31)
时间窗: Day 31
Complete cure will be determined by a minimum of a 12- point reduction on day 17 in the Clinical Symptom Severity Score (from \>20 to \<8) on a scale of 0-64. Improvement is expressed as a lower score.
Incidence of Adverse Events
时间窗: Duration of the study, 31 days for each participant.
Number of moderate A/E possibly related to treatment
Number of Participants With Therapeutic Failure: Post Treatment (Day 17)
时间窗: Day 17
Positive fungi colonization via mycological culture OR microscopic evaluation (KOH) AND a post treatment Clinical Symptom Severity Score of ≤ 8 (0-64) on Day 17. Improvement is expressed as a lower score.
Number of Participants withTherapeutic Failure: Post Treatment Day 31 AND a Post Treatment Clinical Symptom Severity Score (Day 31) of < 8.
时间窗: Day 31
Positive fungi colonization via mycological culture OR microscopic evaluation (KOH) AND a post treatment Clinical Symptom Severity Score of ≤ 8 (0-64) on Day 31. Improvement is expressed as a lower score.
Number of Participants With Complete Cure: Post Treatment (Day 17)
时间窗: Day 17
Complete cure will be determined by negative fungal culture or negative microscopic evaluation via KOH preparation and a Clinical Symptom Severity Score of ≤ 8 (0-64) on Day 17. Improvement is expressed as a lower score.
次要结局
- Change in Participants Clinical Symptom Severity Score Between Day 1 and Day 31(Day 1 and 31)