Lichen Sclerosus of External Female Genital OrgansNCT06079645
Lichen Sclerosus - Treatment With Triamcinolone Acetonide: Injections (Syringe and Needle) x Micro Injections (MMP Technique)
A study testing Infiltration of triamcinolone acetonide (2mg/ml) through syringes and needles and Infiltration of triamcinolone acetonide (40 mg/ml) with needles in people with Lichen Sclerosus of External Female Genital Organs, run by Clinica Dermatologica Arbache ltda at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lichen Sclerosus of External Female Genital Organs
- What is being tested?
- Infiltration of triamcinolone acetonide (2mg/ml) through syringes and needles and Infiltration of triamcinolone acetonide (40 mg/ml) with needles
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Oct 2023to 14 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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),
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- 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,
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clinica Dermatologica Arbache Ltda
São José dos Campos, São Paulo, 12245 760
About this study
Official title: Triamcinolone Acetonide Injections Compared With Micro Injections (MMP Technique) of Triamcinolone Acetonide for the Treatment of Female Genital Lichen Sclerosus and Atrophic
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
- Being tested
- Infiltration of triamcinolone acetonide (2mg/ml) through syringes and needles, Infiltration of triamcinolone acetonide (40 mg/ml) with needles
- Keywords
- acetonide, triamcinolone, Vulvar Diseases, Administration, Cutaneous, Syringes, Tattooing
- Medical subject headings
- Vulvar Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infiltration of triamcinolone acetonide (2mg/ml) through syringes and needlesProcedure or surgery
Infiltration of triamcinolone acetonide (2mg/ml) through syringes and needles
Infiltration of triamcinolone acetonide (40 mg/ml) with needlesProcedure or surgery
Infiltration of triamcinolone acetonide (40 mg/ml) through needles of tattoo machine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (1)
evaluate the safety of both interventions
ulcers, telangiectasias and local atrophies. Local or systemic infections.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start20 Oct 2023
- Primary completion14 May 2025
- Study completion14 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lichen Sclerosus of External Female Genital OrgansStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Dermatologica Arbache ltda
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SAMIR ARBACHE, Clinica Dermatologica Arbache ltda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079645
- Sponsor's protocol ID
- 003
- Status last verified
- Jan 2026
- First submitted
- 6 Oct 2023
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be continuously shared with the Ethics Committee
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 15785050Ventolini 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 22258061Gunthert 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 22759453Arbache 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 37011024Mazdisnian 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triamcinolone Acetonide Injections Compared With Micro Injections (MMP Technique) of Triamcinolone Acetonide for the Treatment of Female Genital Lichen Sclerosus and Atrophic
- ClinicalTrials.gov ID
- NCT06079645
- Acronym / sponsor ID
- 003
- Keywords
- acetonide, triamcinolone, Vulvar Diseases, Administration, Cutaneous, Syringes, Tattooing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Clinica Dermatologica Arbache ltdaUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 14 May 2025 (actual)
- Study completion
- 14 Jun 2025 (actual)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Triamcinolone acetonide (2mg/ml) injections through syringes and needles | Active comparator | Procedure: Infiltration of triamcinolone acetonide (2mg/ml) through syringes and needlesTriamcinolone 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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,
Key exclusion criteria (15 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infiltration of triamcinolone acetonide (2mg/ml) through syringes and needlesInfiltration of triamcinolone acetonide (2mg/ml) through syringes and needles | Procedure or surgery | Triamcinolone acetonide (2mg/ml) injections through syringes and needles |
| Infiltration of triamcinolone acetonide (40 mg/ml) with needlesInfiltration of triamcinolone acetonide (40 mg/ml) through needles of tattoo machine | Procedure or surgery | – |
Primary outcome
Scoring System for Vulvar Lichen Sclerosus
Time frame: one year
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.
1 secondary outcome
evaluate the safety of both interventions
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Background: PubMed 15785050Stucker 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.
- Background: PubMed 22258061Ventolini 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.
- Background: PubMed 22759453Gunthert 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.
- Background: PubMed 37011024Arbache 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.
- Results publication: PubMed 10319301Mazdisnian 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.
- Individual participant dataSharing planned: Yes. Data will be continuously shared with the Ethics Committee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infiltration of triamcinolone acetonide (2mg/ml) through syringes and needles and Infiltration of triamcinolone acetonide (40 mg/ml) with needles in people with Lichen Sclerosus of External Female Genital Organs, run by Clinica Dermatologica Arbache ltda at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scoring System for Vulvar Lichen Sclerosus (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06079645, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.