The Efficacy of CELEXT07 in the Treatment of Toenail Onychomycosis: a Phase 2, Randomized, Double-blind Study
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 52 Weeks
研究概览
简要总结
This will be an interventional safety and efficacy study of CELENT07 when used as a topical treatment of onychomycosis in the toenails (tinea unguium) of adults 18 years and older. This is randomized, double-blind, parallel design, placebo and active controlled study in patients with mild to moderate toenail distal lateral subungual onychomycosis (DLSO) (n=120). Subjects will be randomized (1:1:1) to receive CELENXT07, placebo of CELENXT07 or PENLAC®, daily for 52 weeks. Efficacy assessments will include complete cure, mycologic cure and clinical efficacy and safety and tolerability.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are eligible to be included in the study only if they meet all of the following criteria:
- •Clinically diagnosed onychomycosis of the target nail.
- •Presence of mild to moderate onychomycosis, defined as 20-50% of the area of the target nail being clinically affected.
- •Has a positive KOH examination from the target nail.
- •Has a positive dermatophyte culture from the target nail.
- •Written informed consent obtained.
- •Subject agreed to follow the protocol.
- •Exclusion Criteria
- •Subjects will be excluded from the study if they meet any of the following criteria:
- •Presence of any disease or condition that might cause nail abnormalities or may interfere with the evaluation of the study drug.
- •Use of any systemic antifungal therapy within 4 weeks prior to the Screening visit or non-responsive to systemic antifungal therapy for onychomycosis.
- •Use of any prescription or over-the-counter topical antifungal therapy for the toenails within 4 weeks prior to the Screening visit.
- •Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period.
- •Inability to understand and comply with the instructions of the study
- •Patients less than age 18
- •Individuals with known allergy/hypersensitivity to Thuja occidentalis, Chelidonium majus, Eucalyptus citriodora, Tea tree or Thymus vulgaris.
排除标准
- 未提供
研究组 & 干预措施
CELEXT07
suspension that is applied topically to the infected nail(s) daily.
干预措施: CELEXT07 (Drug)
placebo
placebo is a suspension that simulates the physical properties of the experimental agent CELEXT07. It is applied topically to the infected nail(s) daily.
干预措施: vehicle solution (Other)
Penlac
Is a standard of care for the condition and is applied topically to the infected nail(s) daily.
干预措施: Penlac (Drug)
结局指标
主要结局
Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 52 Weeks
时间窗: week 52
Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes. and no residual involvement of the target toenail. The complete cure is a composite binary variable defined as "Yes" if: * Mycological cure (negative KOH and negative culture for dermatophytes) and * No residual involvement of the target toenail "No" if otherwise
次要结局
- Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 52 Weeks.(week 52)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(week 52)
- Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 52 Weeks.(week 52)