NCT03336372撤回早期 1 期
Picato for the Treatment of Molluscum Contagiosum in Immunocompromised Patients
Center for Clinical Studies, Texas1 个研究点 分布在 1 个国家开始时间: 2017年12月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Complete clearance at Week 4
研究概览
简要总结
Patients at least 18 years of age will be enrolled in the study to assess the efficacy and tolerability of Picato gel in the treatment of molluscum contagiosum. Patients must have an immunocompromised condition due to taking immunosuppressive drugs or having an inherited disease affecting the immune system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or non-pregnant female at least 18 years of age.
- •Subject must have an immunocompromised condition due to use of immunosuppressive therapies for cancer or autoimmune disease treatment or prevention of organ transplant rejection or due to an inherited condition that affects the immune system.
- •Subject has at least 10 clinically typical, visible and discrete MCs within a treatment area on either the face and/or trunk. Treatment area is defined as either:
- •One contiguous treatment area of at most 100 cm2
- •Two non-contiguous treatment areas totaling at most 100 cm2
- •Subject must be willing to forego any other treatments of MC on the face and/or trunk, including tanning bed use and excessive sun exposure, throughout the duration of the trial.
- •Subject is willing and able to participate in the study as an outpatient, making frequent visits to the study center during the treatment and follow-up periods, and to comply with all study requirements.
- •Female subjects of childbearing potential must have a negative urine pregnancy test prior to trial treatment.
- •Female subjects of childbearing potential must be willing to use effective contraception at trial entry and until the last follow-up visit at Week 24.
排除标准
- •Location of the treatment area
- •on the periorbital skin
- •within 5 cm of an incompletely healed wound
- •within 10 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC).
- •Previous participation in an ingenol mebutate trial.
- •Treatment with ingenol mebutate gel in the treatment area within 6 months or outside of the treatment area within 30 days prior to study treatment initiation.
- •Receipt of the following within 90 days prior to study treatment initiation:
- •interferons or interferon inducers
- •any dermatologic procedures or surgeries within the treatment area
- •Receipt of any topical prescription medications in the treatment area within 30 days prior to study treatment initiation.
- •Lesions in the treatment area have atypical clinical appearance (e.g. giant lesions greater than 5 mm, eczematous lesions, or folliculocentric lesions).
- •Active dermatologic conditions that may confound the diagnosis of MC or would interfere with assessment of treatment, such as scabies, cutaneous lymphoma, or psoriasis.
- •Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a severe AE or interfere with assessments of safety and efficacy during the course of the trial, as determined by the (sub)investigator's clinical judgment.
- •Known history of infection with Human Immunodeficiency Virus (HIV).
- •History of melanoma.
- •History of chronic alcohol or drug abuse within 12 months prior to screening, or any condition associated with poor compliance as judged by the (sub)investigator.
- •Known or suspected allergy or reaction to any component of the IMP formulation.
- •Patients who have experienced a clinically important medical event within 90 days prior to study treatment initiation (e.g., stroke, myocardial infarction, etc).
- •Pregnant, breastfeeding, or lactating women.
- •Participation in any another interventional clinical trial within 30 days prior to study treatment initiation.
研究组 & 干预措施
Picato topical gel
Experimental
干预措施: Picato (Drug)
结局指标
主要结局
Complete clearance at Week 4
时间窗: 4 weeks
Complete clearance is defined as no clinically visible MCs in the treatment area/
次要结局
- Partial clearance at Week 4(4 weeks)
- Percentage of subjects who sustain complete clearance of MCs in the treatment area at Week 24(24 weeks)
- Percentage of subjects who clear MCs outside of the treatment area at Week 24(24 weeks)
研究者
研究点 (1)
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