Safety and Efficacy Study of SKX-16 in Participants With Mild to Moderate Distal Subungual Onychomycosis
A Phase 2, Multicenter, Randomized, Double-Blind Study Evaluating the Safety and Efficacy of SKX-16 (Luliconazole 10% Solution) in Participants With Mild to Moderate Distal Subungual Onychomycosis of the Toenails
This is a parallel group, double blind, vehicle-controlled study in which SKX-16 or vehicle (2:1 randomization) is applied once a day for 52 weeks to all affected toenails to participants with mild to moderate distal subungual onychomycosis (DSO) of the toenails involving between 20 to 50% of at least one great toenail at Screening.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：Mehria Afzal Patient Recruitment and Site Engagement Specialist
- 电话号码：326 866-575-3111
- 邮箱：mafzal@inderocro.com
学习地点
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California
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Los Angeles、California、美国、900045
- SKX16B01 Clinical Study - Site 105
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接触：
- Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
- 电话号码：866-575-3111
- 邮箱：mafzal@inderocro.com
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San Francisco、California、美国、94115
- SKX16B01 Clinical Study - Site 101
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接触：
- Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
- 电话号码：866-575-3111
- 邮箱：mafzal@inderocro.com
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Florida
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Miami、Florida、美国、11760
- SKX16B01 Clinical Study - Site 104
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接触：
- Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
- 电话号码：866-575-3111
- 邮箱：mafzal@inderocro.com
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Miami、Florida、美国、33126
- SKX16B01 Clinical Study - Site 109
-
接触：
- Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
- 电话号码：866-575-3111
- 邮箱：mafzal@inderocro.com
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Texas
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College Station、Texas、美国、77845
- SKX16B01 Clinical Study - Site 111
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接触：
- Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
- 电话号码：866-575-3111
- 邮箱：mafzal@inderocro.com
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Houston、Texas、美国、77027
- SKX16B01 Clinical Study - Site 119
-
接触：
- Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
- 电话号码：866-575-3111
- 邮箱：mafzal@inderocro.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Participant is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures.
- Male or female participant of any race aged 18 to 70 years, inclusive, at the time of consent.
- Participants with a clinical diagnosis of DSO, involving 20%-50% of at least one of the great toenails at screening.
- Participants must have no more than 5 toes with suspected presence of onychomycosis (ie, no more than a total of 5 infected toenails, including ≤3 non-great toenails and up to 2 great toenails) at screening.
- Participant's target great toenail must have no involvement of the lunula (matrix) and have ≥ 4 mm of clear (unaffected) nail distal from the proximal nail fold at screening.
- Clinical judgment supports that the historical growth rate of the target great toenail will permit monthly toenail clipping during the study.
- Participant must be willing and able to comply with all study procedures and must be available for the duration of the study.
Exclusion Criteria:
- Participant is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
- Participant has a history or presence of a skin condition on the feet that, in the opinion of the investigator, would interfere with the study assessments.
- Participant is known to have immune deficiency or is immunocompromised.
- Participant has continuous onychomycosis of the toenail(s) for ≥ 5 consecutive years immediately prior to Screening visit without any intervening period of complete resolution (information obtained from medical chart or participant's physician, or directly from the participant).
- Participant has fingernails with suspected presence of onychomycosis.
- Participant has disease involvement confined exclusively to the lateral edge of the target great toenail.
- Participant has "spike" of onychomycosis extending to eponychium of the target great toenail.
- Participant had a major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study.
- Participant has any clinically significant medical condition or physical/laboratory/vital signs abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of study results.
- Participant has a known history of chronic infectious disease (eg, hepatitis B, hepatitis C, or human immunodeficiency virus [HIV]).
- Participant has a known history of diabetes and an HbA1C ≥ 8% at screening.
- Participant has reported to have previously failed a standard course of oral antifungal treatment for onychomycosis.
- Participant received prior laser treatment, photodynamic therapy, or chemical or surgical treatment for onychomycosis within the last 12 months prior to Day 1.
- Participant has used any prescription or OTC topical antifungal therapy for the toenails within 4 weeks prior to Day 1.
- Participant has used systemic antifungal therapies within 6 months prior to Day 1.
- Participant has used any topical medicated treatment applied to the feet within 2 weeks prior to Day 1, including but not limited to, anti-inflammatory medications, topical corticosteroids, or topical immunomodulators.
- Participant is currently receiving an investigational product or device for any indication, or has received one within 4 weeks prior to Day 1 (excluding investigational products in trials pertaining to Exclusion Criterion #32).
- Participant is unwilling to refrain from the use of other prescription or OTC onychomycosis treatments, nail cosmetics on their toenails (including nail lacquers), or pedicures from the screening visit until the end of the study.
- Participant has a known or suspected hypersensitivity or allergy to luliconazole or imidazole compounds or the excipients of the formulation.
- Participant has a known history of clinically significant drug or alcohol abuse in the last year prior to Day 1.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Active Arm
SKX-16 (Luliconazole 10% Solution) |
Applied topically once daily for 52 weeks to all affected toenails identified by the investigator, followed by a Week 56 follow-up visit. |
|
安慰剂比较：Vehicle Arm
Vehicle solution that does not contain active ingredients. |
Applied topically once daily for 52 weeks to all affected toenails identified by the investigator, followed by a Week 56 follow-up visit, under the same conditions as the active arm. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Complete Cure at Week 56
大体时间：56 weeks
|
Proportion of participants who achieve Complete Cure of the target toenail at Week 56, as defined by clinical cure (completely clear target great toenail as assessed by the investigator) and mycological cure (negative KOH microscopy and negative culture) |
56 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mycological Cure at Week 56
大体时间：56 weeks
|
Proportion of participants with mycological cure (negative KOH microscopy and negative culture) of the target toenail at Week 56 |
56 weeks
|
|
Clinical Cure at Week 56
大体时间：56 weeks
|
Proportion of participants with clinical cure (completely clear target great toenail as assessed by the investigator) at Week 56 |
56 weeks
|
|
≤5% Affected Nail Area + Mycological Cure at Week 56
大体时间：56 weeks
|
Proportion of participants with ≤ 5% of affected target toenail area and mycological cure of the target toenail at Week 56 |
56 weeks
|
|
<10% Affected Nail Area + Mycological Cure at Week 56
大体时间：56 weeks
|
Proportion of participants with < 10% of affected target toenail area and mycological cure of the target toenail at Week 56 |
56 weeks
|
|
Percent Change in Affected Nail Area
大体时间：Baseline and Week 56
|
Percent change from baseline in percentage of affected target toenail area at Week 56 |
Baseline and Week 56
|
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Clear Nail Growth at Week 56
大体时间：56 weeks
|
Clear nail growth of the target toenail at Week 56 |
56 weeks
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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