Status:
UNKNOWN
Lichen Sclerosus - Treatment With Triamcinolone Acetonide: Injections (Syringe and Needle) x Micro Injections (MMP Technique)
Lead Sponsor:
Clinica Dermatologica Arbache ltda
Conditions:
Lichen Sclerosus of External Female Genital Organs
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
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 cortiso...
Detailed Description
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 infi...
Eligibility Criteria
Inclusion
- 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
- 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,
Key Trial Info
Start Date :
October 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 2 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06079645
Start Date
October 20 2023
End Date
April 2 2025
Last Update
October 23 2023
Active Locations (1)
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1
Clinica Dermatologica Arbache Ltda
São José dos Campos, São Paulo, Brazil, 12245 760