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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 4
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 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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• 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,

Locations
Other Locations
Brazil
Clinica Dermatologica Arbache Ltda
RECRUITING
São José Dos Campos
Contact Information
Primary
SAMIR ARBACHE, PHD MD
samir@dermocentro.com.br
+55 12 981221011
Backup
SAMIA ARBACHE, MD
samia.arbache@gmail.com
+55 11 964981831
Time Frame
Start Date: 2023-10-20
Estimated Completion Date: 2025-04-02
Participants
Target number of participants: 20
Treatments
Active_comparator: Triamcinolone acetonide (2mg/ml) injections through syringes and needles
Triamcinolone at a concentration of 2mg/ml will be injected on one side of the randomized vulva using a syringe and needle.
Active_comparator: Triamcinolone acetonide (40mg/ml) through microinjections with needles
Triamcinolone at a concentration of 40mg/ml will be injected on the other side of the randomized vulva using a tattoo machine.
Related Therapeutic Areas
Sponsors
Leads: Clinica Dermatologica Arbache ltda

This content was sourced from clinicaltrials.gov