Clinical trial NCT03200808: Methylene Blue Injection for Nonneoplastic Epithelial Disorders of Vulva
Official title: Evaluation of the Efficacy of Mixed Methylene Blue Compound Injection for the Treatment of Nonneoplastic Epithelial Disorders of Vulva.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Nonneoplastic Epithelial Disorders of Vulva
Keywords: Nonneoplastic Epithelial Disorders
methylene blue
treatment
Lead sponsor: Maternal and Child Health Hospital of Hubei Province
Sponsor class: OTHER
First posted: 2017-06-27
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pations with nonneoplastic epithelial disorders（NNEDS） of vulva.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Methylene blue compound injection are mixed by Methylene Blue injection, Dexamethasone powder-injection, Ropivacaine injection and Normal saline injection. Each individual component can help in a very wide range of medical conditions without serious side effects.

In this study，the investigators used methylene blue compound injection intradermally to treat NNEDs patients. Patients with a diagnosis of biopsy proven NNEDs from Maternal and Child Health Hospital of Hubei Province (China) between October 2013 to October 2016 were recruited. Every patient received intradermal mixed methylene blue compound injection twice. All patients were observed during the hospitalization at the first injection, and two weeks later they received the second injection at the outpatient department. Ages, itching scores, percentage of hypopigmented skin, and recurrences were recorded through inquiry and physical examination before and after treatment. Side effects (such as edema, fever and vulva pain) were also recorded. All women were followed up 1, 3, 6, 12 months after treatment, which included inquiry and physical examination.

Eligibility criteria: Inclusion Criteria:

* Patients with clinically and biopsy confirmed non-neoplasia epithelial disorders of skin and mucosa of vulva.
* Patient must have a score of 5 or greater in the itching score table before treatment and the itching must last at least 6 months.

Exclusion Criteria:

* Patients with vulvovaginal or other gynecological trauma, acute inflammatory diseases and other acute illness
* Patients have been treated with any kind of topical therapy at the vulva within 12 weeks prior to participation in the study
* Patients with other serious diseases (e.g. liver or kidney diseases) that need immediate treatment
* Patients with atypical vulvar hyperplasia or vulvar cancer confirmed by biopsy

Primary outcomes:
measure: itching scores
timeFrame: 1 years
Secondary outcomes:
measure: percentage of hypopigmented skin
timeFrame: 1 years
Other outcomes:
measure: pathology changes
timeFrame: 1 years
Locations:
Study officials:
affiliation: Maternal and Child health Hospital of Hubei Province,Wuhan,China
name: Han Gao, bachelor
role: STUDY_DIRECTOR
affiliation: Maternal and Child health Hospital of Hubei Province,Wuhan,China
name: Xufeng Wu, PH.D
role: STUDY_CHAIR
affiliation: Maternal and Child health Hospital of Hubei Province,Wuhan,China
name: Yanli Li, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.