Methylene Blue Injection for Nonneoplastic Epithelial Disorders of Vulva

What Was Tested

The trial (phase 1) is built around Methylene blue (non-peptide stack partner).

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.

It had 1 arm (groups): treatment group (experimental).

The registry classes the interventions as drug.

More on the Plan

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.

Every patient received intradermal mixed methylene blue compound injection twice.

Who Took Part

118 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Methylene blue (non-peptide stack partner) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2013-10-01 with completion listed for 2018-10-01.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: itching scores (time frame: 1 years).

It also tracked 1 secondary outcome, for example percentage of hypopigmented skin.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Methylene blue (non-peptide stack partner) in 118 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.