Pilot study of vulval lichen sclerosus treatment by adipose tissue associated with autologous platelet-rich plasma

Instituto de Investigación Sanitaria La Fe0 个研究点目标入组 30 人开始时间: 2017年5月8日最近更新: 2020年2月1日

适应症

试验速览

暂无简介。

•Adult women between 18 and 70 years old
•Patients with clear clinical and / or histological diagnosis of lichen sclerosus
•Vulvar biopsy existence at some point in patient’s medical history to exclude malignant or pre-malignant disease
•Moderate or severe disease at genital level
•Patients who have had topical treatment for at least three months with 0.05% clobetasol propionate.
•Informed consent previously signed.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 25
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•Pregnant or lactating women
•Alcoholic patients
•Patients with malignant disease diagnosed in the last 5 years
•Patients infected with HIV, HBV and HCV virus
•Injecting drug users
•Patients with serious active infectious diseases.
•Patients with allergy or intolerance recognized for any of the above treatments
•Patients with inflammatory diseases that may affect the vulvar area (Crohn's disease, ulcerative colitis, Psoriasis, Eczema).
•Patients with unrealistic expectations regarding the ultimate benefits of treatment

发起方

Instituto de Investigación Sanitaria La Fe