A Double-Blind, Randomized, Vehicle-Control, Multicenter Study to Evaluate the Efficacy and Safety of NAFT900 in Children With Tinea Capitis Aged 6 to < 13 Years
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Compare the proportion of subjects with complete cure
研究概览
简要总结
A Double-Blind, Randomized, Vehicle-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of NAFT-900 in Children Aged 6 to < 13 Years with Tinea Capitis
详细描述
This is an 8-week double-blind, randomized, vehicle-controlled, multicenter study of NAFT-900 compared to vehicle in the treatment of tinea capitis in children ≥6 years to <13 years of age.
There will be approximately 60 subjects enrolled. Qualifying subjects with clinical evidence of a tinea capitis infection involving ≤ 15% of the scalp, confirmed by positive culture, will be randomized 2:1 to one of the following treatments:
- NAFT-900 (Naftifine hydrochloride foam, 3%)
- Vehicle Foam The study will consist of up to 6 visits. Subjects will apply the assigned study product twice daily to the affected area(s) for 4 weeks
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with clinical diagnosis of tinea capitis with ≤15% involvement of the scalp.
- •Subjects with positive KOH microscopy and culture [for dermatophytes].
- •Male or female subjects ≥6 years and <13 years of age on the date of the Baseline Visit.
排除标准
- •Subject with acute inflammatory fungal infection of the scalp (kerion)
- •Subjects with skin disease on the scalp, or any other condition or prior/present treatment which in the opinion of the investigator would interfere with the study drug's effect or assessments (e.g., psoriasis, seborrheic dermatitis).
- •Subjects who received immunosuppressant therapy, cytostatic therapy or radiation therapy within 4 weeks prior to the baseline.
- •Subjects who received systemic corticosteroids and/or systemic antibiotics within 4 weeks prior to study entry (or during study).
- •Subjects who have used systemic antifungal treatment within 4 weeks prior to the baseline.
- •Subjects who have used antifungal agents, corticosteroid preparations, ketoconazole, ciclopirox, salicylic acid, terbinafine, amorolfine, butenafine, clotrimazole, econazole, oxiconazole, sertaconazole, sulconazole, luliconazole, fluconazole, benzoic acid, griseofulvin, undecylenic acid, zinc pyrithione or selenium sulfide, or tar containing topical treatments for their scalp within 1 week prior to the baseline visit.
- •Subjects with a life-threatening condition (ex. autoimmune deficiency syndrome, cancer, unstable angina, or myocardial infarction) within the last 6 months prior to baseline visit.
研究组 & 干预措施
NAFT900
NAFT900 (Naftifine hydrochloride foam, 3%)
干预措施: Naftifine hydrochloride foam, 3% (Drug)
Vehicle
Vehicle Foam
干预措施: Vehicle (Drug)
结局指标
主要结局
Compare the proportion of subjects with complete cure
时间窗: 8 weeks
Complete cure defined as negative KOH microscopy, negative dermatophyte culture and a score of 0 on baseline signs
次要结局
- Compare the proportion of subjects with an effective treatment(8 weeks)
- Compare the proportion of subjects with mycological cure(8 weeks)