A two-part (observational and intervention) study to explore disease characteristics of vulvar (pre)malignancies compared to healthy volunteers - Deep phenotyping of vulvar (pre)malignant disease.

Centre for Human Drug Research0 个研究点目标入组 40 人2020年7月17日

适应症lichen sclerosus, vulvar (pre)malignancies Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: lichen sclerosus, vulvar (pre)malignancies
发起方: Centre for Human Drug Research
入组人数: 40
状态: 进行中（未招募）
最后更新: 4年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2020年7月17日

结束日期

待定

最后更新

4年前

研究类型

Interventional clinical trial of medicinal product

性别

Female

研究者

发起方

Centre for Human Drug Research

入排标准

入选标准

•1\. Non\-pregnant female subjects, 25\-95 years of age (inclusive); in general, stable good health as per judgment of the investigator based upon the results of a medical history, physical examination (BMI \= 30\) and vital signs.
•2\. If female of childbearing potential, have a negative urine pregnancy test at Day 0\.
•3\. Willing to give written informed consent and willing and able to comply with the study protocol.
•4\. Ability to communicate well with the investigator in the Dutch or English language.
•5\. Subject is willing to undergo vulvar biopsies.
•6\. Subject is willing to refrain from washing (including bathing, swimming, showering and excessive sweating) the vulva counting from midnight of every study visit day.
•7\. Subject is willing to refrain from application of products (e.g. ointments, crème or wash) on the vulva 24 hours prior to every study visit day.
•8\. Subject is willing to refrain from sexual intercourse less than 24 hours prior to every study visit.
•9\. Subject is willing to refrain from shaving, waxing or other hair removing treatments in the perineal area in the 24 hours prior to every study visit.
•10\. Willing to refrain from any active treatment for vulvar HSIL and LS as from 14 days prior to Day 0\.

排除标准

•1\. Significant, uncontrolled or unstable disease in any organ system as per judgment of the investigator (regardless of association with the immunosuppressing disorder/therapy), including but not limited to: psychiatric, neurologic, cardiovascular, pulmonary, gastrointestinal, hepatic, renal, endocrine, hematologic or respiratory disease.
•2\. History of immunological abnormality (e.g., immune suppression) that may interfere with study objectives, in the opinion of the investigator.
•3\. Known infection requiring (topical or oral) antibiotic therapy within 28 days prior to Day 0;
•4\. The use of any oral/systemic medication (e.g. immunomodulatory, immunosuppressive, acetylsalicylic acid) within 28 days prior to Day 0, if the investigator judges that it may interfere with the study objectives. The use of paracetamol (up to 4 g/day) is allowed;
•5\. Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding;
•6\. Self\-reported: (a) immunocompromised state, (b) sexually transmitted disease, (c) AIDS and/or (d) hepatitis.
•7\. Have any current and / or recurrent clinically significant or subject reported skin condition in the vulvar area other than the vulvar disease wherefore subject is included in the study.
•Eligible vulvar patients must meet none of the following exclusion criteria at screening:
•8\. Have any current relevant (inflammatory) skin infections in the treatment area other than the observational disease (vulvar LS, vulvar HSIL of VSCC), inclusively, but not limited to atopic dermatitis, herpes, candidiasis or psoriasis.
•9\. Have used or received any topical vulvar HSIL treatment, laser therapy or surgery in the anogenital area within 28 days prior to Day 0