ISRCTN86355789已完成不适用
Randomised, blind and placebo-controlled trial for the CIGB-300 perilesional application in two dose levels in the recurrent and non recurrent genital condyloma
aboratorio Elea SACIFyA (Argentina)0 个研究点目标入组 132 人开始时间: 2010年10月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 132
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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 21 and 65 years inclusive
排除标准
- •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
研究者
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