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Completed

NCT Number: NCT06079645

Lichen Sclerosus - Treatment With Triamcinolone Acetonide: Injections (Syringe and Needle) x Micro Injections (MMP Technique)

This research is about a genital disease known as Lichem Sclerosus and Atrophic. It mainly affects women over 18 years of age. The treatment will involve injections of a medicine that contains cortisone, using two different methods: with a syringe and a needle or with a tattoo machine. Before and after treatment, they will see if women feel pain, itching, burning, scratching or difficulty having sexual intercourse.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Dermatologica Arbache Ltda

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

About this study

There is evidence that injectable triamcinolone has an effect on reducing the symptoms of lichen sclerosus and atrophic. After randomizing the vulva, the vulva will be anesthetized with lidocaine infiltrations. After 15 minutes, interventions will begin. Triamcinolone will be injected using two different techniques: syringes & needles in one side and with tattoo machine (MMP technique) in other side. The outcomes will be evaluated according to the criteria of pain, itching, burning, itching and difficulty in sexual penetration

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical and/or histopathological diagnosis of genital (vulvar, perineal or perianal) Lichen Sclerosus and Atrophicus (LEA),
  • Failure to regress symptoms after topical treatment with potent topical corticosteroid for at least 3 months,
  • 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,

Treatment and study plan

Infiltration of triamcinolone acetonide (2mg/ml) through syringes and needles

Procedure

Infiltration of triamcinolone acetonide (2mg/ml) through syringes and needles

Infiltration of triamcinolone acetonide (40 mg/ml) with needles

Procedure

Infiltration of triamcinolone acetonide (40 mg/ml) through needles of tattoo machine

Primary outcomes

  1. Scoring System for Vulvar Lichen Sclerosus

    Time frame: one year

    On each side of the randomized vulva, symptoms of itching, burning, pain and dyspareunia will be assessed before and after the intervention. The assessment will be carried out by the patient herself, on a scale of zero to 10, with zero being asymptomatic and 10 when the symptom is unbearable.

Secondary outcomes

  1. evaluate the safety of both interventions

    Time frame: one year

    ulcers, telangiectasias and local atrophies. Local or systemic infections.

Sponsors and collaborators

Lead sponsor

Clinica Dermatologica Arbache ltda

Other

Registry information

Official study title

Triamcinolone Acetonide Injections Compared With Micro Injections (MMP Technique) of Triamcinolone Acetonide for the Treatment of Female Genital Lichen Sclerosus and Atrophic

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 12, 2023
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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