CTRI/2017/11/010647招募中2 期
A multi-center, randomized, double-blind, vehicle-controlled, phase-2 trial to evaluate the efficacy and safety of two concentrations of topical povidone-iodine nail solution (VBP-926) for the treatment of chemotherapy-associated paronychia in cancer patients.
Joseph Capriotti0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
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. Males or females aged 18 years or older
- •2. Acute paronychia developing during the course of their EGFRI, taxane, MEK inhibitor or mTOR inhibitor monotherapy or combination chemotherapy
- •3. Involvement of at least one nail with a Paronychia Severity Grading score of 1 or higher
- •4. Eastern Cooperative Oncology Group score <= 2
- •5. Life expectancy of at least 12 months as per the investigatorâ??s judgment
- •6. Willing to provide written informed consent
- •7. Individuals who are willing to not start any new products OTC or prescription treatments for Paronychia and discontinue any treatment the investigator feels may interfere with the evaluation of the test products
- •8. Individuals who are already on antibiotics as prescribed by oncologist for any condition except paronychia
- •9. Individuals who are willing to avoid using cosmetic products, creams, salves, or ointments to the treatment area(s)
- •10. Female subjects of childbearing age with negative pregnancy test at the enrolment time in the study
- •11. Female subjects who are not breastfeeding at the enrolment time in the study
- •12. Female subjects that do not intend to become pregnant during their participation in the study
- •13. Female subjects with reproductive potential must agree to practice medically acceptable form of birth control during the study
- •Medically acceptable forms of birth control that may be used by the subject and/or his/her partner include: Established use of hormonal methods of contraception (oral, injected, implanted, patch or vaginal ring) Barrier methods of contraception with spermicide: condom or occlusive cap (diaphragm or cervical/Vault caps) with a spermicidal foam/gel/film/cream or suppository: Intrauterine device or intrauterine system Surgical sterilization (vasectomy, tubal occlusion, bilateral salpingectomy)
- •Abstinence from heterosexual intercourse; when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are NOT acceptable methods of contraception
排除标准
- •Patients meeting the following exclusion criteria will be excluded:
- •1. Mentally incompetent or unable or not willing to give written informed consent or meet study requirements
- •2. Without a history of a cancer diagnosis
- •3. Without history of cancer diagnosis using EGFRI, taxane, MEK inhibitor or mTOR inhibitor chemotherapy
- •4. Patients with paronychia requiring surgical intervention at baseline
- •5. Patients who are already on prescribed treatment for paronychia who are not willing to discontinue this treatment and only use study drug (no washout period required)
- •6. Known history of hypersensitivity to topical povidone-iodine.
- •7. Neutropenia (absolute neutrophil count < 1500 cells/µL)
- •8. Patient with Human Immunodeficiency Virus (HIV) infection
- •9. Patients with any medical condition, including alcohol or drug abuse or mental incapacity / hypersensitive to the study drug, which in judgment of the investigator will interfere with the patientâ??s participation in the study or evaluation of study results
- •10. Have any medical condition that, in the opinion of the investigator, may interfere with the study results or place the subject at undue risk
研究者
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