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

Primary Purpose

Lichen Sclerosus of External Female Genital Organs

Status
Recruiting
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Infiltration of triamcinolone acetonide (2mg/ml) through syringes and needles
Infiltration of triamcinolone acetonide (40 mg/ml) with needles
Sponsored by
Clinica Dermatologica Arbache ltda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lichen Sclerosus of External Female Genital Organs focused on measuring acetonide, triamcinolone, Vulvar Diseases, Administration, Cutaneous, Syringes, Tattooing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: 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, 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,

Sites / Locations

  • Clinica Dermatologica Arbache LtdaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

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

Triamcinolone acetonide (40mg/ml) through microinjections with needles

Arm Description

Triamcinolone at a concentration of 2mg/ml will be injected on one side of the randomized vulva using a syringe and needle.

Triamcinolone at a concentration of 40mg/ml will be injected on the other side of the randomized vulva using a tattoo machine.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

evaluate the safety of both interventions
ulcers, telangiectasias and local atrophies. Local or systemic infections.

Full Information

First Posted
October 6, 2023
Last Updated
October 18, 2023
Sponsor
Clinica Dermatologica Arbache ltda
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1. Study Identification

Unique Protocol Identification Number
NCT06079645
Brief Title
Lichen Sclerosus - Treatment With Triamcinolone Acetonide: Injections (Syringe and Needle) x Micro Injections (MMP Technique)
Official Title
Triamcinolone Acetonide Injections Compared With Micro Injections (MMP Technique) of Triamcinolone Acetonide for the Treatment of Female Genital Lichen Sclerosus and Atrophic
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2023 (Anticipated)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 2, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinica Dermatologica Arbache ltda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lichen Sclerosus of External Female Genital Organs
Keywords
acetonide, triamcinolone, Vulvar Diseases, Administration, Cutaneous, Syringes, Tattooing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Triamcinolone acetonide (2mg/ml) injections through syringes and needles
Arm Type
Active Comparator
Arm Description
Triamcinolone at a concentration of 2mg/ml will be injected on one side of the randomized vulva using a syringe and needle.
Arm Title
Triamcinolone acetonide (40mg/ml) through microinjections with needles
Arm Type
Active Comparator
Arm Description
Triamcinolone at a concentration of 40mg/ml will be injected on the other side of the randomized vulva using a tattoo machine.
Intervention Type
Procedure
Intervention Name(s)
Infiltration of triamcinolone acetonide (2mg/ml) through syringes and needles
Intervention Description
Infiltration of triamcinolone acetonide (2mg/ml) through syringes and needles
Intervention Type
Procedure
Intervention Name(s)
Infiltration of triamcinolone acetonide (40 mg/ml) with needles
Intervention Description
Infiltration of triamcinolone acetonide (40 mg/ml) through needles of tattoo machine
Primary Outcome Measure Information:
Title
Scoring System for Vulvar Lichen Sclerosus
Description
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 Outcome Measure Information:
Title
evaluate the safety of both interventions
Description
ulcers, telangiectasias and local atrophies. Local or systemic infections.
Time Frame
one year

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
treatment will only be carried out in women
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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, 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,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SAMIR ARBACHE, PHD MD
Phone
+55 12 981221011
Email
samir@dermocentro.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
SAMIA ARBACHE, MD
Phone
+55 11 964981831
Email
samia.arbache@gmail.com
Facility Information:
Facility Name
Clinica Dermatologica Arbache Ltda
City
São José Dos Campos
State/Province
SÃO Paulo
ZIP/Postal Code
12245 760
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SAMIR ARBACHE
Phone
+55 12 981221011
Email
samir@dermocentro.com.br
Phone
+55 12 39221400

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be continuously shared with the Ethics Committee
IPD Sharing Time Frame
18 months
IPD Sharing Access Criteria
reports will be sent continuously to the ethics committee
Citations:
PubMed Identifier
15785050
Citation
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.
Results Reference
background
PubMed Identifier
22258061
Citation
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.
Results Reference
background
PubMed Identifier
22759453
Citation
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. Erratum In: J Sex Med. 2020 Sep;17(9):1825.
Results Reference
background
PubMed Identifier
37011024
Citation
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.
Results Reference
background
PubMed Identifier
10319301
Citation
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.
Results Reference
result

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

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