A Pilot, Randomized, Blinded, Controlled Study Evaluating Autologous Platelet-Rich Plasma for the Treatment of Vulvar Lichen Sclerosus

Jennifer R. Arthurs1 个研究点分布在 1 个国家目标入组 30 人2022年1月19日

适应症Vulvar Lichen Sclerosus

干预措施Autologous Platelet-Rich Plasma (PRP)Sham Procedure

概览

阶段: 1 期
干预措施: Autologous Platelet-Rich Plasma (PRP)
疾病 / 适应症: Vulvar Lichen Sclerosus
发起方: Jennifer R. Arthurs
入组人数: 30
试验地点: 1
主要终点: Incidence of adverse events
状态: 进行中（未招募）
最后更新: 2个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

The purposes of this study are to determine the safety and feasibility of autologous platelet-rich plasma for the treatment of vulvar lichen sclerosus, and to determine the efficacy of autologous platelet-rich plasma for the treatment of vulvar lichen sclerosus.

注册库

clinicaltrials.gov

开始日期

2022年1月19日

结束日期

2026年6月2日

最后更新

2个月前

研究类型

Interventional

研究设计

Parallel

性别

Female

研究者

发起方

Jennifer R. Arthurs

责任方

Sponsor Investigator

主要研究者

Jennifer R. Arthurs

Sponsor-Investigator

Mayo Clinic

入排标准

入选标准

•Female, ages 18 years and greater.
•Females of childbearing potential must have a negative pregnancy test prior to receiving the study drug and will agree to use adequate contraception (hormonal or barrier method or abstinence) from the time of screening to a period of 1 year following completion of the drug treatment cycle. Females of childbearing potential are defined as premenopausal and not surgically sterilized, or post-menopausal for fewer than 2 years. A urine pregnancy test will be performed prior to the administration of the study drug to confirm negative results. If the urine pregnancy test is positive, the study drug will not be administered and the result will be confirmed by a serum pregnancy test. Serum pregnancy tests will be performed at a central clinical laboratory, whereas urine pregnancy tests will be performed by qualified personnel using kit.
•Females becoming pregnant during the study will continue to be monitored for the duration of the study or completion of the pregnancy, whichever is longer. Monitoring will include perinatal and neonatal outcome. Any SAEs associated with pregnancy will be recorded.
•Diagnosis of Lichen Sclerosus.
•On a maintenance regimen of topical clobetasol for Lichen Sclerosus. Maintenance is defined as use of topical clobetasol 3 or fewer days per week. For patients with a new diagnosis of Lichen Sclerosus, they will complete 6 weeks of topical clobetasol ointment twice daily prior to enrollment in the study with transition to a maintenance regimen during study.
•Completed general physical evaluation with primary care provider within 12 months of enrollment.
•Full understanding of the requirements of the study and willingness to comply with protocol.
•Can provide written informed consent and complete HIPAA documentation after the nature of the study is fully explained and prior to any study-related procedure

排除标准

•Pregnant or nursing, or planning on becoming pregnant during the study period.
•Clinically significant abnormal hematology (complete blood count with differential).
•Taking anticoagulant medications (e.g., warfarin, heparin) or clopidogrel (Plavix).
•Taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within 3 months prior to study enrollment.
•On chronic, immunosuppressive transplant therapy or having a chronic, immunosuppressive state, including use of systemic steroids/corticosteroids.
•Using topical steroids on affected area and unable to stop for the 6 week washout period prior to beginning the study. Topical steroid use will be exclusionary throughout week 12 of the study for patients randomized to receive PRP.
•Current tobacco product use, including nicotine patch or other nicotine products.
•Ongoing infectious disease, including but not limited to tuberculosis, HIV, hepatitis, and syphilis.
•Clinically significant cardiovascular (e.g., history of myocardial infarction, congestive heart failure or uncontrolled hypertension \> 90 mmHg diastolic and/or 180 mmHg systolic), neurologic (e.g., stroke, TIA) renal, hepatic, or endocrine disease (e.g., diabetes).
•History of cancer/malignancy with the exception of adequately treated basal cell or squamous cell carcinoma of the skin within the last 5 years.