Treatment for Lichen Sclerosus using Triamcinolone Injections

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

This study is testing two different ways of giving triamcinolone injections to see which one helps women with Lichen Sclerosus feel better by reducing pain, itching, and discomfort during sex.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Clinica Dermatologica Arbache ltda (Academic / other)
• Locations: 1 site (São José Dos Campos, SÃO Paulo)
• Trial ID: NCT06079645 on ClinicalTrials.gov

What this trial studies

This clinical trial focuses on treating Lichen Sclerosus, a genital disease affecting women, through injections of triamcinolone acetonide. Participants will receive treatment using two different methods: traditional syringes and needles, and a tattoo machine technique. The study will assess the effectiveness of these methods by evaluating symptoms such as pain, itching, and difficulty with sexual intercourse before and after treatment. The trial aims to provide insights into the best approach for alleviating symptoms associated with this condition.

Who should consider this trial

Good fit: Ideal candidates are women over 18 years old with a clinical diagnosis of Lichen Sclerosus who have not responded to topical corticosteroid treatments.

Not a fit: Patients with other skin diseases or those who have not adhered to previous treatment protocols may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the symptoms of Lichen Sclerosus, improving the quality of life for affected women.

How similar studies have performed: While there is evidence supporting the use of injectable triamcinolone for this condition, the specific techniques being tested in this trial are novel.

Eligibility criteria

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,

Where this trial is running

São José Dos Campos, SÃO Paulo

• Clinica Dermatologica Arbache Ltda — São José Dos Campos, SÃO Paulo, Brazil (Recruiting)

Study contacts

• Study coordinator: Samir Arbache, Phd Md

Conditions Lichen Sclerosus of External Female Genital Organs; acetonide, triamcinolone; Vulvar Diseases; Administration, Cutaneous; Syringes; Tattooing