Tattoo machine vs. needle: new hope for women with genital skin disease?
NCT ID NCT06079645
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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20 people
The number who actually took part.
- Started
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Oct 2023
- Finished
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Jun 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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Clinica Dermatologica Arbache Ltda
São José dos Campos, São Paulo, 12245 760, Brazil