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临床试验/NCT03017846
NCT03017846已完成2 期

Safety and Efficacy of Topical Cantharidin for the Treatment of Molluscum Contagiosum, Phase 2

Steven R Cohen1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Number of Participants With Total Lesion Clearance

研究概览

简要总结

Cantharidin is cited in the dermatology and pediatric literature as a valuable treatment option. Treatment is often available in private practice offices, where a prescribing physician may offer a non-FDA approved treatment on an individualized basis. The situation is different in many hospital and academic settings, such as our own for example, where the formulary is defined through a FDA-approved indication. The absence of an indication precludes its addition to many hospital formularies, thus limiting the options available to a prescribing physician and denying patient access to a treatment offered in the private practice setting. An indication and formulary status require controlled clinical trials on the safety and efficacy of cantharidin in MC. The objective of this trial is to see if this commercially-viable cantharidin formulation has a comparable safety and efficacy profile as formulations previously studied under conditions which most closely match the what has been historically done in the clinic.

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
2 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of MC by the Principal Investigator.
  • Maximum of 50 lesions on locations including the face, trunk, back, left or right arm, left or right leg, hands, feet, buttocks, and groin.
  • Execution of Informed Consent and or assent forms

排除标准

  • Patients with immunosuppression, including organ transplantation, HIV infection.
  • Patients utilizing immunosuppressive agents (including oral corticosteroids) will be excluded except for patients using inhaled corticosteroids, such as those utilized for asthma or allergic rhinitis.
  • Females who have reached menarche and are sexually active as well as pregnant patients will be excluded as the effects of this drug have not been evaluated in pregnancy.
  • Patients who have greater than 50 MC lesions will also be excluded from the study.

研究组 & 干预措施

Cantharidin Treatment

Experimental

Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks.

干预措施: Cantharidin (Drug)

结局指标

主要结局

Number of Participants With Total Lesion Clearance

时间窗: Assessed at each visit, until final visit on week 12

100% reduction in baseline lesion count

次要结局

  • Number of Patients Achieving Complete Lesion Clearance Compared to Prior Study (NCT02665260)(At study completion, up to 12 weeks)
  • Number of Subjects Who Achieve a Clearance of at Least 90% of Their Molluscum Lesions(At study completion, up to 12 weeks)
  • Change in the Total Children's Dermatology Life Quality Index Score(Baseline (At beginning of study, before treatment) and end of study (at study completion, week 12 or at earlier visit if all lesions have cleared))

研究者

发起方
Steven R Cohen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Steven R Cohen

Professor

Montefiore Medical Center

研究点 (1)

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