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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triamcinolone acetonide (2mg/ml) injections through syringes and needles | Active Comparator | Triamcinolone at a concentration of 2mg/ml will be injected on one side of the randomized vulva using a syringe and needle. |
|
| Triamcinolone acetonide (40mg/ml) through microinjections with needles | Active Comparator | Triamcinolone at a concentration of 40mg/ml will be injected on the other side of the randomized vulva using a tattoo machine. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infiltration of triamcinolone acetonide (2mg/ml) through syringes and needles | Procedure | Infiltration of triamcinolone acetonide (2mg/ml) through syringes and needles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Scoring System for Vulvar Lichen Sclerosus | 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. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| evaluate the safety of both interventions | ulcers, telangiectasias and local atrophies. Local or systemic infections. | one year |
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Inclusion Criteria:
Exclusion Criteria:
treatment will only be carried out in women
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Dermatologica Arbache Ltda | São José dos Campos | São Paulo | 12245 760 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15785050 | Background | Stucker M, Grape J, Bechara FG, Hoffmann K, Altmeyer P. The outcome after cryosurgery and intralesional steroid injection in vulvar lichen sclerosus corresponds to preoperative histopathological findings. Dermatology. 2005;210(3):218-22. doi: 10.1159/000083513. | |
| 22258061 | Background | Ventolini G, Swenson KM, Galloway ML. Lichen sclerosus: a 5-year follow-up after topical, subdermal, or combined therapy. J Low Genit Tract Dis. 2012 Jul;16(3):271-4. doi: 10.1097/LGT.0b013e31823da7e8. |
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Data will be continuously shared with the Ethics Committee
18 months
reports will be sent continuously to the ethics committee
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Prospective, randomized pilot study involving 20 participants with genital LEA, refractory to the use of high-potency topical corticosteroid therapy. In this investigation.
The vulvas will be randomized as right side and left side
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| Infiltration of triamcinolone acetonide (40 mg/ml) with needles | Procedure | Infiltration of triamcinolone acetonide (40 mg/ml) through needles of tattoo machine |
| 22759453 | Background | Gunthert AR, Duclos K, Jahns BG, Krause E, Amann E, Limacher A, Mueller MD, Juni P. Clinical scoring system for vulvar lichen sclerosus. J Sex Med. 2012 Sep;9(9):2342-50. doi: 10.1111/j.1743-6109.2012.02814.x. Epub 2012 Jul 3. |
| 37011024 | Background | Arbache S, Hirata SH. Efficacy and Safety of 5-Fluorouracil Tattooing to Repigment Idiopathic Guttate Hypomelanosis: A Split-Body Randomized Trial. Dermatol Surg. 2023 Jun 1;49(6):603-608. doi: 10.1097/DSS.0000000000003793. Epub 2023 Apr 3. |
| 10319301 | Result | Mazdisnian F, Degregorio F, Mazdisnian F, Palmieri A. Intralesional injection of triamcinolone in the treatment of lichen sclerosus. J Reprod Med. 1999 Apr;44(4):332-4. |
| ID | Term |
|---|---|
| D014845 | Vulvar Diseases |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D009339 | Needles |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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