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Methylene Blue Injection for Nonneoplastic Epithelial Disorders of Vulva

NCT03200808 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2022-11-14

No results posted yet for this study

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

Interventions

DRUG

mixed methylene blue compound injection

Every patient received intradermal mixed methylene blue compound injection twice.

Sponsors & Collaborators

  • Maternal and Child Health Hospital of Hubei Province

    lead OTHER

Principal Investigators

  • Han Gao, bachelor · Maternal and Child health Hospital of Hubei Province,Wuhan,China

  • Xufeng Wu, PH.D · Maternal and Child health Hospital of Hubei Province,Wuhan,China

  • Yanli Li, Master · Maternal and Child health Hospital of Hubei Province,Wuhan,China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-01
Primary Completion
2018-10-01
Completion
2019-10-17

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03200808 on ClinicalTrials.gov