CClinicalTrials.gg
Sign In
CompletedNCT06079645Updated Jan 21, 2026

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

An interventional study of Infiltration of triamcinolone acetonide (2mg/ml) through syringes and needles and Infiltration of triamcinolone acetonide (40 mg/ml) with needles in Lichen Sclerosus of External Female Genital Organs, sponsored by Clinica Dermatologica Arbache ltda. Completed at 1 site in Brazil. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-21.

Sponsored by Clinica Dermatologica Arbache ltda · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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

02

Conditions studied

  • Lichen Sclerosus of External Female Genital Organs

Keywords

  • acetonide, triamcinolone
  • Vulvar Diseases
  • Administration, Cutaneous
  • Syringes
  • Tattooing
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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),
  • 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,
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • 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.

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

  • 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.

Interventions

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

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

  • ProcedureInfiltration of triamcinolone acetonide (40 mg/ml) with needles

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

05

What researchers measure

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.

    Time frame: one year

Secondary outcomes

  1. evaluate the safety of both interventions

    ulcers, telangiectasias and local atrophies. Local or systemic infections.

    Time frame: one year

06

Study locations

1 site
  • Clinica Dermatologica Arbache Ltda
    São José dos Campos, São Paulo 12245 760, Brazil
07

References and documents

Publications

  • 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. PubMed 15785050 ↗
  • 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. PubMed 22258061 ↗
  • 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. PubMed 22759453 ↗
  • 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. PubMed 37011024 ↗
  • 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. PubMed 10319301 ↗

Individual participant data

Plan to share: Yes — Data will be continuously shared with the Ethics Committee

Supporting information: Study protocol, Csr

08

Registry details

Key details

Study ID
NCT06079645
Lead sponsor
Clinica Dermatologica Arbache ltda
Responsible party
SAMIR ARBACHE (PHD, Clinica Dermatologica Arbache ltda) — Principal investigator
First posted
Oct 12, 2023
Start date
Oct 20, 2023
Primary completion
May 14, 2025
Completion
Jun 14, 2025
Last update
Jan 21, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Vulvar Diseases

Other studies from this sponsor

Clinica Dermatologica Arbache ltda

Start the discussion