Lichen Sclerosus - Treatment With Triamcinolone Acetonide: Injections (Syringe and Needle) x Micro Injections (MMP Technique)

NCT06079645 | Completed DMC

• 1 other identifier: 003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Lichen Sclerosus of External Female Genital Organs

Keywords

acetonide, triamcinolone; Vulvar Diseases; Administration, Cutaneous; Syringes; Tattooing

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• evaluate the safety of both interventions

  one year

Study Arms (2)

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.

Procedure: Infiltration of triamcinolone acetonide (2mg/ml) through syringes and needles

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.

Interventions

Infiltration of triamcinolone acetonide (2mg/ml) through syringes and needles PROCEDURE

Infiltration of triamcinolone acetonide (2mg/ml) through syringes and needles

Triamcinolone acetonide (2mg/ml) injections through syringes and needles

Infiltration of triamcinolone acetonide (40 mg/ml) with needles PROCEDURE

Infiltration of triamcinolone acetonide (40 mg/ml) through needles of tattoo machine

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: treatment will only be carried out in women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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),

Sponsors & Collaborators

• Clinica Dermatologica Arbache ltda: lead

Study Sites (1)

Clinica Dermatologica Arbache Ltda

São José dos Campos, São Paulo, 12245 760, Brazil

Location

Related Publications (5)

• 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.

  PMID: 15785050 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.

  PMID: 22258061 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.

  PMID: 22759453 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.

  PMID: 37011024 BACKGROUND

• 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.

  PMID: 10319301 RESULT

MeSH Terms

Conditions

Vulvar Diseases

Interventions

Needles

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD

Model Details: 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

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 12, 2023
• Study Start: October 20, 2023
• Primary Completion: May 14, 2025
• Study Completion: June 14, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 18 months
• Access Criteria: reports will be sent continuously to the ethics committee

Locations

BR (1)