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

NCT ID: NCT06079645

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-20
• Study Completion Date: 2025-06-14

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.

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 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

Conditions

Lichen Sclerosus of External Female Genital Organs

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

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

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.

Group Type: ACTIVE_COMPARATOR

No interventions assigned to this group

Interventions

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

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

Intervention Type: PROCEDURE

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

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Clinical and/or histopathological diagnosis of genital (vulvar, perineal or perianal) Lichen Sclerosus and Atrophicus (LEA),

2. Failure to regress symptoms after topical treatment with potent topical corticosteroid for at least 3 months,

3. Progressive deformity of the vulva, clitoris, perineal or perianal region during treatment with potent topical corticosteroids,

Exclusion Criteria

• 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),

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Clinica Dermatologica Arbache ltda

OTHER

Sponsor Role: lead

Responsible Party

SAMIR ARBACHE

PHD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clinica Dermatologica Arbache Ltda

São José dos Campos, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: BACKGROUND

PMID: 15785050 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22258061 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22759453 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37011024 (View on PubMed)

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.

Reference Type: RESULT

PMID: 10319301 (View on PubMed)

Other Identifiers

003

Identifier Type: -

Identifier Source: org_study_id