Last updated 14 months ago
Lichen Sclerosus - Treatment With Triamcinolone Acetonide: Injections (Syringe and Needle) x Micro Injections (MMP Technique)
20 patients around the world
Available in Brazil
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
Clinica Dermatologica Arbache ltda
20Patients around the world
This study is for people with
Lichen
Lichen sclerosus
Requirements for the patient
From 18 Years
Female
Medical requirements
- 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,
- 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,
SponsorClinica Dermatologica Arbache ltda
Conditions
Lichen sclerosus
Requirements
From 18 YearsFemale
Unique study IDclinicaltrials.gov
NCT06079645
