A Phase 4, Double-Blind, Randomized, Vehicle-Controlled, Multicenter, Parallel Group Evaluation of the Efficacy and Safety of Naftin (Naftifine Hydrochloride) Cream, 2% in Pediatric Subjects With Tinea Corporis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 19
- 主要终点
- Primary Efficacy
研究概览
简要总结
The study is being done to see how well the study cream works when applied once a day to affected area of child (where they have ringworm). The results will be compared to those seen with a placebo cream which has no active ingredient. Safety of the cream will also be measured.
详细描述
The objectives of this study are to evaluate the safety and efficacy of Naftin (naftifine hydrochloride) Cream, 2% applied once daily for 2 weeks, compared to its vehicle in the treatment of pediatric subjects aged 2 to 17 years and 11 months with positive potassium hydroxide (KOH), positive dermatophyte culture, and clinical signs and symptoms of tinea corporis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or non-pregnant females 2 years of age to 17 years, 11 months, of any race. Females of child bearing potential must have a negative urine pregnancy test.
- •Presence of tinea corporis by clinical evidence of a tinea infection of at least moderate erythema, moderate induration, and mild pruritus.
- •KOH positive and culture positive baseline skin scrapings obtained form the site with the mose severely affected lesion or a representative site of the overall severity.
排除标准
- •Tinea infection of the face, scalp, groin, and/or feet
- •A life-threatening condition in the opinion of the investigator (ex. autoimmune deficiency syndrome, cancer, etc) within the last 6 months.
- •Subjects with abnormal findings- physical or laboratory- that are considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of study results
- •Subjects with a known hypersensitivity or other contradictions to study medications or their components.
- •Subjects who have a recent history or who are currently known to abuse alcohol or drugs.
- •Uncontrolled diabetes mellitus.
- •Hemodialysis or chronic ambulatory peritoneal dialysis therapy.
- •Current diagnosis of immunocompromising conditions.
- •Current evidence of compromised skin, atopic or contact dermatitis, eczema, impetigo, lichen planus, pityriasis rosea, pityriasis versicolor, psoriasis, seborrhoeic dermatitis and syphilis.
- •Severe dermatophytoses, mucocutaneous candidiasis, or bacterial skin infection
- •Patients with tinea corporis who have concurrent dermatophytosis of the scalp, beard or nails.
研究组 & 干预措施
Naftin Cream, 2%
Once Daily
干预措施: Naftin Cream (Drug)
Placebo Cream
Once Daily
干预措施: Placebo Cream (Drug)
结局指标
主要结局
Primary Efficacy
时间窗: Day 21
Complete cure defined by negative KOH result and negative dermatophyte culture
次要结局
- Secondary Efficacy(Day 21)