Methylene Blue Injection for Nonneoplastic Epithelial Disorders of Vulva
Status:
Unknown status
Trial end date:
2018-05-01
Target enrollment:
Participant gender:
Summary
The aim of this study is to demonstrate the safety and effectiveness of mixed methylene blue
compound Injection for the treatment of nonneoplastic epithelial disorders（NNEDS） of vulva.
NNEDS of skin and mucosa of vulva refer to a group of chronic diseases including squamous
hyperplasia and lichen sclerosus, which mainly cause vulvar itching and hypopigmentation.
Usually the itching is severe may influence social activities and sleep. In addition, NNEDS
cause scarring of the vulva which may cause significant sexual dysfunction or pain. The
reasons for NNEDs are not clear and the methods of treatment are diverse. The current
treatments are primarily local drug (e.g. steroid, calcineurin inhibitors, immunosuppressive
agents ), surgical treatments, laser or photodynamic therapy, and the "gold standard"
treatment for lichen sclerosus is potent steroids creams. However, all the treatments are not
good enough, and the diseases often recur and severely affect women's quality of life. So the
investigators reviewed plenty of literatures, and found some authors used single intradermal
1% methylene blue injection for intractable idiopathic pruritus ani and the effect was good.
As a preliminary experiment, the investigators used intradermal mixed methylene blue compound
injection for a NNEDs patient in the year of 2012, the itching of the patient stopped
immediately and the color of the vulva recovered 6 months later. The patient keeps healthy
till now. And from then on, the investigators designed this study and to verify the effect
and complications of intradermal mixed methylene blue compound injection for the treatment of
NNEDS. So far, there is no similar study reported internationally.
Phase:
Phase 1
Details
Lead Sponsor:
Maternal and Child Health Hospital of Hubei Province