jRCT2031230342进行中（未招募）不适用
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Candin (Candida albicans Skin Test Antigen for Cellular Hypersensitivity) for the Treatment of Common Warts (Verruca vulgaris) in Adolescents and Adults (CFW-3A)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 330
- 主要终点
- complete resolution of the treatment wart without recurrence
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 12age old over 至 No limit（—）
- 性别
- All
入选标准
- •Subjects 12 years of age and older at the time of signing the ICF.
- •Otherwise healthy (no ongoing medical condition that would prohibit enrollment in this study per the opinion of the Investigator).
- •At least 3, but no more than 20, common warts (Verruca vulgaris) per the opinion of the Investigator, at least 2 of which are suitable for selection as measured warts. Lesions that could potentially be non warts should not be included in the common wart count. If there is any uncertainty about the classification of certain lesions, the Medical Monitor should be contacted before the subject is enrolled.
- •At least 1 of the common warts is located on the hands (excluding palms and palmar aspect of fingers), feet (excluding soles and plantar aspect of toes), limbs, and/or trunk, which is suitable for selection as the treatment wart.
- •For adults, mentally and legally capable of giving informed consent prior to any study related procedures. For adolescents, parent and adolescent are mentally and legally capable of giving informed consent/assent prior to any study related procedures.
- •Female subjects (assigned female at birth) are eligible to participate in the study if they are not pregnant or breastfeeding, if they do not intend to get pregnant during the study, and if they agree to comply with the contraception and reproduction restrictions of the study as follows:
- •a.Female subjects of childbearing potential must be using a method of contraception that is highly effective (i.e., < 1% failure rate) for at least 30 days prior to the first injection (Screening Visit) and at least 90 days following the last injection.
- •b.Highly effective forms of birth control used by females include abstinence, hormonal contraceptives [oral, patch, injectable or vaginal ring], and implantable device [implantable rod or intrauterine device]. If taking hormonal contraceptives, subjects must be on a stable dose since at least 30 days before the first injection (Screening Visit).
- •c.Postmenopausal subjects must be at least 55 years of age and have had no menstrual bleeding for at least 1 year before initial injection at the Screening Visit or deemed postmenopausal by the Investigator (provided the subject has not experienced menstrual bleeding in the past year).
- •d.Female subjects of childbearing potential must have evidence of a negative urine pregnancy test result at the Baseline Visit.
- •All male subjects (assigned male at birth), from the day of initial injection until the final study visit, unless surgically sterile, must be willing to use a condom with a partner (male subjects with partners of childbearing potential must be willing to use 2 effective methods of birth control, 1 should be condom with spermicide) (For Japan, male subjects with partners of childbearing potential must be willing to use one effective method of birth control such as condom etc.) to prevent pregnancy and drug exposure of a partner, and must refrain from donating sperm for fathering a child for 90 days following the last injection.
排除标准
- •Presence of systemic or localized diseases, conditions, or medications that could interfere with the assessment of safety or efficacy or that compromise immune function, in the opinion of the investigator.
- •Candin delayed type hypersensitivity (DTH) reaction test delayed wheal sized < 5 mm or > 25 mm at the Baseline Visit.
- •History of keloid formation.
- •Treatment with immunotherapy (e.g., diphenylcyclopropenone (DPCP), dinitrochlorobenzene (DNCB), or other), imiquimod, 5-fluorouracil, bleomycin, or podophyllin within 12 weeks of the Baseline Visit or during the study.
- •Prior treatment with Candida albicans within 12 weeks of the Baseline Visit or during the study.
- •Systemic treatment with an immunosuppressive drug during the study or in the 6 months or 5 half-lives prior to the Baseline Visit or during the study (e.g., azathioprine, 6-mercaptopurine, methotrexate, infliximab, adalimumab, etanercept, systemic steroids (topical or inhaled steroids are acceptable)).
- •Use of cantharidin, coix seed extract, or any other treatments for warts (including over-the-counter products) within the 30 days prior to the Baseline Visit or during the study.
结局指标
主要结局
complete resolution of the treatment wart without recurrence
时间窗: 12 weeks after the last injection
The percentage of subjects who achieve complete resolution of the treatment wart without recurrence for 12 weeks after the last injection.
次要结局
- Time from first injection to achieving clinical clearance of the treatment wart
- Proportion of subjects with clinical clearance of at least 50% of all measured warts(Follow-up Visit #2)
- Proportion of subjects with clinical clearance of all measured warts(Follow-up Visit #2)
研究者
相似试验
招募中
1 期
A Study to Evaluate Atezolizumab and Bevacizumab, with and without Tiragolumab, In Patients With Untreated Locally Advanced or Metastatic Hepatocellular CarcinomaHepatocellular Carcinoma (HCC)MedDRA version: 21.1Level: LLTClassification code: 10077738Term: Hepatocellular carcinoma metastatic Class: 10029104CTIS2023-503422-39-00F. Hoffmann-La Roche AG659
进行中（未招募）
1 期
Ph 3 Placebo-Controlled Trial of Adjuvant MK-3475 in RCC Post NephrectomyTreatment of participants with RCC in the adjuvant settingMedDRA version: 21.0Level: LLTClassification code 10038395Term: Renal carcinomaSystem Organ Class: 100000004864EUCTR2016-004351-75-ITMERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.950
进行中（未招募）
1 期
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems. - Phase III Study of Epratuzumab in Severe Acute SLE FlaresClassification code 10042945Systemic Lupus ErythematosusEUCTR2005-000705-59-SKImmunomedics, Inc.510
进行中（未招募）
1 期
A study to evaluate Chemotherapy Plus Osimertinib against Chemotherapy Plus Placebo in patients with non-small cell lung cancer (NSCLC)on-Small Cell Lung CancerMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-003969-18-ITASTRAZENECA AB204
进行中（未招募）
1 期
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study toEvaluate the Safety and Efficacy of Dutogliptin in Patients with Type 2 DiabetesMellitus on Background Treatment with Glimepiride with or without MetformiType 2 diabetes mellitus (T2DM)MedDRA version: 12.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusEUCTR2009-012597-13-HUForest Research Institute, Inc.650