Methylene Blue Injection for Nonneoplastic Epithelial Disorders of Vulva

NCT03200808 | Completed Phase 1 DMC

• 1 other identifier: NNEDs
• Study Type: interventional
• Target: 118
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nonneoplastic Epithelial Disorders of Vulva

Keywords

Nonneoplastic Epithelial Disorders; methylene blue; treatment

Outcome Measures

Primary Outcomes (1)

• itching scores

  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.

  1 years

Secondary Outcomes (1)

• percentage of hypopigmented skin

  1 years

Other Outcomes (1)

• pathology changes

  1 years

Study Arms (1)

treatment group

EXPERIMENTAL

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. 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.

Drug: mixed methylene blue compound injection

Interventions

mixed methylene blue compound injection DRUG

Every patient received intradermal mixed methylene blue compound injection twice.

treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Maternal and Child Health Hospital of Hubei Province: lead

Related Publications (3)

• 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.

  PMID: 20854400 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.

  PMID: 22669483 BACKGROUND

• 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.

  PMID: 31628667 DERIVED

Study Officials

• Han Gao, bachelor

  Maternal and Child health Hospital of Hubei Province,Wuhan,China

  STUDY DIRECTOR

• Xufeng Wu, PH.D

  Maternal and Child health Hospital of Hubei Province,Wuhan,China

  STUDY CHAIR

• Yanli Li, Master

  Maternal and Child health Hospital of Hubei Province,Wuhan,China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pations with nonneoplastic epithelial disorders（NNEDS） of vulva.

Study Record Dates

• First Submitted: June 25, 2017
• First Posted: June 27, 2017
• Study Start: October 1, 2013
• Primary Completion: October 1, 2018
• Study Completion: October 17, 2019
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share