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Recurrent and Nonrecurrent Condyloma Treatment

2015年3月11日 更新者：Laboratorio Elea Phoenix S.A.

Randomised, Blind and Placebo-controlled Trial for the CIGB-300 Perilesional Application in Two Dose Levels in the Recurrent and Non Recurrent Genital Condyloma

Treatment is considered successful if the difference in the response in the reduction of the affected area is above 30% for any of the doses compared to placebo Patients will be randomised to 1 of 3 treatment arms

  1. Placebo
  2. CIGB-300 - 5 mg
  3. CIGB-300 - 15 mg

A two week screening visit will take place to assess patient eligibility, at least 2 to 5 target lesions (area of the lesion between 20 to 80 mm2), should be identified. Patients included in the study will be randomly assigned to one of three study arms. Treatment consists of 3 perilesional applications at the base of the target lesion every 48 hours with a window of ±24hs.

After each application the potential local and systemic adverse events will be identified and monitored.

After the last application is made, weekly clinical evaluations for 3 weeks and then every two weeks, until week 12 will take place. At this time, clinical assessment of efficacy will be carried out that will define the response to treatment.

After this visit, patients will be followed every 3 months until one year after the last treatment has been completed to confirm response and long-term security of the CIGB-300 application.

At screening, at 2 and 8 weeks as well as at 6 and 12 months post-treatment blood studies will be conducted to assess the safety from the systemic point of view.

研究概览

地位

终止

条件

干预/治疗

研究类型

介入性

注册 (实际的)

132

阶段

  • 阶段2
  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 阿根廷
    • Buenos Aires
      • Capital Federal、Buenos Aires、阿根廷、C1417AZE
        • Laboratorio Elea SACIFyA

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

  1. Informed consent signed by the patient
  2. Women with clinical diagnosis of recurrent and non recurrent genital condyloma
  3. Presence of a condylomatous lesion or area of external confluent condylomatous lesions of not less than 20 or more than 80 mm2
  4. The number of warts should be between 2 and 20
  5. External genital warts or in perigenital regions
  6. Negative pregnancy test
  7. Age between 18 and 65 years inclusive

Exclusion Criteria:

  1. Having received surgery treatment, ablative or immunomodulator treatment during the 30 days prior to inclusion
  2. Presence of genital warts only located in the cervix, vagina, bladder or rectum
  3. Pregnancy and lactation
  4. Patients of childbearing age who are not using an adequate contraception method during treatment to prevent pregnancy.
  5. Inadequately controlled chronic diseases (hypertension, diabetes, chronic kidney failure, heart failure, hyperthyroidism, malignant neoplasms, epilepsy, severe mental depression)
  6. Patients with previous diagnosis of bleeding disorders and other chronic blood disorders (von Willebrand disease, haemophilia, leukaemia) or use of anticoagulants within 30 days before the study
  7. Current genital herpes, which requires application of topical antivirals
  8. Immunosuppressive disease, current intake of immunosuppressive/ immunomodulatory drugs within 30 days before the study.
  9. Autoimmune Diseases (Lupus Erythematosus, Rheumatoid Arthritis, Multiple Sclerosis, Diabetes)
  10. Severe allergy history as urticaria, dermatitis or persistent bronchitis and bronchial asthma
  11. Febrile illness (temperature greater than 38ºC) at the time or within 24 hours prior to administration of the product or suspected acute infectious disease by clinical examination
  12. Diseases that compromise the patient's consciousness or the ability to give informed consent or to collaborate in the study
  13. Concomitant skin lesions that prevent the administration of condylomatous lesions at the proposed site
  14. Participating in another clinical trial

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

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：三倍

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：安慰剂
药品：PROAPOPTOTIC PEPTIDE CIGB 300
CIGB 300,in INTRALESIONAL on day 3 of each 48 HOURS.
实验性的：CIGB-300 - 5 mg
药品：PROAPOPTOTIC PEPTIDE CIGB 300
CIGB 300,in INTRALESIONAL on day 3 of each 48 HOURS.
实验性的：CIGB-300 - 15 mg
药品：PROAPOPTOTIC PEPTIDE CIGB 300
CIGB 300,in INTRALESIONAL on day 3 of each 48 HOURS.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Number of patients with complete response of target lesion in each study group
大体时间：Up to one year
Up to one year
Number of patients with adverse events during the application of the study drug
大体时间：Up to one year
Up to one year

次要结果测量

结果测量
大体时间
Effect of the perilesional application of CIGB300 in the reduction in the number and area of genital warts lesions treated directly
大体时间：Up to one year
Up to one year
Locoregional effect of CIGB300 by assessing the area and number of genital warts lesions not directly treated
大体时间：Up to one year
Up to one year
Effect of CIGB300 to avoid recurrence of the lesions
大体时间：Up to one year
Up to one year
Optimal dose, in comparison with placebo
大体时间：Up to one year
Up to one year
Number of patients with adverse events
大体时间：Up to one year
Up to one year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Laboratorio Elea Phoenix S.A.

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年6月1日

初级完成 (实际的)

2012年12月1日

研究完成 (实际的)

2014年12月1日

研究注册日期

首次提交

2012年5月14日

首先提交符合 QC 标准的

2012年7月10日

首次发布 (估计)

2012年7月13日

研究记录更新

最后更新发布 (估计)

2015年3月12日

上次提交的符合 QC 标准的更新

2015年3月11日

最后验证

2015年3月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CONDI 02 AR

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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