Methylene Blue Injection for Nonneoplastic Epithelial Disorders of Vulva

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.

Timeline

Start

2013-10-01

Primary completion

2018-10-01

Completion

2019-10-17

Publications

• Background Neill SM, Lewis FM, Tatnall FM, Cox NH; British Association of Dermatologists. British Association of Dermatologists' guidelines for the management of lichen sclerosus 2010. Br J Dermatol. 2010 Oct;163(4):672-82. doi: 10.1111/j.1365-2133.2010.09997.x. No abstract available.
• Background Samalavicius NE, Poskus T, Gupta RK, Lunevicius R. Long-term results of single intradermal 1 % methylene blue injection for intractable idiopathic pruritus ani: a prospective study. Tech Coloproctol. 2012 Aug;16(4):295-9. doi: 10.1007/s10151-012-0846-1. Epub 2012 Jun 6.
• Li Y, Shi J, Tan W, Ma Q, Wu X, Gao H. Prospective observational study of the efficacy of mixed methylene blue compound injection for treatment of vulvar non-neoplastic epithelial disorders. Int J Gynaecol Obstet. 2020 Feb;148(2):157-161. doi: 10.1002/ijgo.13007. Epub 2019 Nov 19.

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Indications