Completed

NCT Number: NCT03200808

Methylene Blue Injection for Nonneoplastic Epithelial Disorders of Vulva

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.

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Key information

Conditions

Nonneoplastic Epithelial Disorders of Vulva

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mixed methylene blue compound injection

Drug

Every patient received intradermal mixed methylene blue compound injection twice.

Primary outcomes

itching scores

Time frame: 1 years

The patients rate the itching on a visual analogue scale (VAS) before and after the treatment. A VAS is a 100-mm long horizontal line with verbal descriptors at each end to express the extremes of the itching feeling. The most severe itching equals to score 10, and no itching equals to score 0. Patients marked the point on the line that best corresponded to their itching severity.

Secondary outcomes

percentage of hypopigmented skin

Time frame: 1 years

Doctors rate the hypopigmented skin on a vulva surface area scale (VSAS) before and after treatment through colposcopy. The vulva area is divided into six regions as labia majora, labia minora, interlabial sulci, clitoris and clitoral hood, perineum, and perianal area. The investigators estimated that the area percentage of labia majora, labia minora, interlabial sulci, clitoris and clitoral hood, perineum, and perianal area was 48%, 24%, 4%, 4%, 10% and 10% differently. Among the six regions, interlabial sulci, clitoris and clitoral hood, perineum, and perianal area could be divided into four equal proportions at most when the area percentage was calculated. And each side of labia majora and labia minora could be divided into four equal proportions at most. If all the vulva area is involved, the VSAS score is 100%, and if no area of vulva is involed, the VSAS score is 0%.

Other outcomes

pathology changes

Time frame: 1 years

changes of nonneoplastic epithelial disorders from biopsy pathology

Sponsors and collaborators

Lead sponsor

Maternal and Child Health Hospital of Hubei Province

Other

Registry information

Official study title

Evaluation of the Efficacy of Mixed Methylene Blue Compound Injection for the Treatment of Nonneoplastic Epithelial Disorders of Vulva.

Acronym: NNEDsMB

Important dates

Study start: 2013
Primary completion: 2018
Study completion: 2019
First posted: Jun 27, 2017
Registry last updated: Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.