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Tattoo machine vs. needle: new hope for women with genital skin disease?

NCT ID NCT06079645

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested two ways to inject a cortisone medicine (triamcinolone acetonide) to treat genital lichen sclerosus, a skin condition causing itching, pain, and discomfort in women. Twenty women who did not improve with standard creams received injections either by a traditional syringe or a tattoo machine. Researchers measured changes in symptoms like pain and itching to see which method worked better.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Started

Oct 2023

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Clinical and/or histopathological diagnosis of genital (vulvar, perineal or perianal) Lichen Sclerosus and Atrophicus (LEA), 2. Failure to regress symptoms after topical treatment with potent topical corticosteroid for at least 3 months, 3. Progressive deformity of the vulva, clitoris, perineal or perianal region during treatment with potent topical corticosteroids, Exclusion Criteria: * Absence of other skin diseases such as lichen planus, psoriasis, Crohn's disease and ulcerative colitis, * Commitment to use at least one form of adequate contraception (hormonal or barrier method) if sexually active or of childbearing potential (premenopausal or postmenopausal women for less than 2 years), * Willingness to fulfill the study requirements. Willing and able to follow the schedule of treatments and follow-up visits, * patient demonstrates mental and psychiatric health, * Signs of good hygiene and evidence that you can apply dressings until the injuries heal, * Diagnosis of pre-malignant or malignant genital (e.g. vulvar dysplasia, intraepithelial neoplasia or carcinoma), * Crural lymphadenopathy, * Absence of urinary incontinence, absence of immunological changes, absence of visceral neoplasia, absence of coagulation disorders (or use of anticoagulants), absence of immunosuppressive treatment (including) systemic corticosteroid therapy. * Patients/participants with previously known allergies or those detected during the interventions (anesthetics, topical antibiotics or other medications used in the trials), * If pregnancy occurs during the trial, the participant will be excluded from the investigation and referred to an obstetrician. If the patient wishes, her genitalia will be clinically monitored during pregnancy and breastfeeding, * Participants who are not collaborative or who are absent from regular visits. * Refusal to treat local infectious diseases that trigger intervention (parasitic, protozoal, bacterial, viral or fungal). * Participant with recurrent genital herpes simplex who refuses to undergo systemic antiviral therapy. * Identification during interventions of allergies to the medications used in the trial (anesthetics, topical antibiotics or other medications used in the trials), * Any disease or condition not explicitly related to the exclusion criteria, which in the investigator's judgment interferes with the participant's ability to comply with the protocol, compromises the participant's safety or interferes with the interpretation of study results,

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Clinica Dermatologica Arbache Ltda

    São José dos Campos, São Paulo, 12245 760, Brazil