Nonneoplastic Epithelial Disorders of VulvaPhase 1NNEDsMBNCT03200808
Methylene Blue Injection for Nonneoplastic Epithelial Disorders of Vulva
A Phase 1 study testing mixed methylene blue compound injection in people with Nonneoplastic Epithelial Disorders of Vulva, run by Maternal and Child Health Hospital of Hubei Province.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nonneoplastic Epithelial Disorders of Vulva
- What is being tested?
- mixed methylene blue compound injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2013to 17 Oct 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to 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.
Who cannot join
- 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
About this study
Official title: Evaluation of the Efficacy of Mixed Methylene Blue Compound Injection for the Treatment of 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.
Read the 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.
- Being tested
- mixed methylene blue compound injection
- Keywords
- Nonneoplastic Epithelial Disorders, methylene blue, treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mixed methylene blue compound injectionDrug
Every patient received intradermal mixed methylene blue compound injection twice.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: mixed methylene blue compound injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 years
Secondary outcomes (1)
percentage of hypopigmented skin
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%.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start1 Oct 2013
- Primary completion1 Oct 2018
- Study completion17 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nonneoplastic Epithelial Disorders of VulvaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pations with nonneoplastic epithelial disorders（NNEDS） of vulva.
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maternal and Child Health Hospital of Hubei Province
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Han Gao, bachelor, Study director, Maternal and Child health Hospital of Hubei Province,Wuhan,ChinaXufeng Wu, PH.D, Study chair, Maternal and Child health Hospital of Hubei Province,Wuhan,ChinaYanli Li, Master, Principal investigator, Maternal and Child health Hospital of Hubei Province,Wuhan,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200808
- Sponsor's protocol ID
- NNEDs
- Acronym
- NNEDsMB
- Status last verified
- Nov 2022
- First submitted
- 25 Jun 2017
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20854400Samalavicius 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.
PubMed 22669483Li 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.
PubMed 31628667
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Mixed Methylene Blue Compound Injection for the Treatment of Nonneoplastic Epithelial Disorders of Vulva.
- ClinicalTrials.gov ID
- NCT03200808
- Acronym / sponsor ID
- NNEDsMB / NNEDs
- Keywords
- Nonneoplastic Epithelial Disorders, methylene blue, treatment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Maternal and Child Health Hospital of Hubei ProvinceUniversity, hospital or other
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 17 Oct 2019 (actual)
- First posted
- 27 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pations with nonneoplastic epithelial disorders（NNEDS） of vulva.
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: mixed methylene blue compound injectionMethylene 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mixed methylene blue compound injectionEvery patient received intradermal mixed methylene blue compound injection twice. | Drug | treatment group |
Primary outcome
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.
1 secondary outcome
percentage of hypopigmented skin
Time frame: 1 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Background: PubMed 20854400Neill 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.
- Background: PubMed 22669483Samalavicius 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.
- Derived from this study: PubMed 31628667Li 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Han Gao, bachelor study director
Maternal and Child health Hospital of Hubei Province,Wuhan,China
Xufeng Wu, PH.D study chair
Maternal and Child health Hospital of Hubei Province,Wuhan,China
Yanli Li, Master principal investigator
Maternal and Child health Hospital of Hubei Province,Wuhan,China
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mixed methylene blue compound injection in people with Nonneoplastic Epithelial Disorders of Vulva, run by Maternal and Child Health Hospital of Hubei Province.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
itching scores (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03200808, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.