To Compare Inflammatory Biomarkers Before and After Treatment With Clobetasol or Fractional CO2 Laser, in Women With Histologically Confirmed Vulvar Lichen Sclerosus, Without Prior Corticosteroid Treatment.

Official title

Vulvar Lichen Sclerosus: Expression of Inflammatory Markers in a Randomized Clinical Trial With Clobetasol Versus Laser

Overview

The present study is a Clinical trial that compares clobetasol ointment versus Fractional CO2 laser for vulvar lichen sclerosus (VLE) treatment confirmed by histology, with no previous treatment. Lichen sclerosus is a chronic inflamatory disease that affects the vulvar skin in the majority of cases, generally in peri and post menopause. The main symptom is pruritus, along with dispareunia and vulvar pain. If not treated, it can leads to vulvar anatomy distortion and altough small, there is risk of neoplastic transformation towards pre cancer and invasive vulvar cancer. Clobetasol ointment is the standard treatment, but prolonged use can cause some adverse effects, such as thinning the skin, fungal infections, and exacerbation of symptoms. Forty participants are being randomized to clobetasol group, three months with reducing frequency and the other group of participants, to fractional dioxid carbon (CO2) laser for three sessions four weeks apart. At the beggining and three months after the completion of each treatment, a punch biopsy will be taken for every participant. The principal aim is to compare some inflamatory biomarkers before and after each treatment and compare them by imunohistoquemestry at Imunology and Imunogenetic Laboratory in Fiocruz, Rio de janeiro, Brazil. Secondary outcomes include clinical response and changes in vulvar anatomy, assessed using the Sheinis \& Selk questionnaire before and after each treatment, as well as the evaluation of some clinical aspects, such as improvement in itching, dyspareunia and appearance of the vulva, along with satisfaction with the treatment, using the Visual Analogue Scale (VAS) from 1 to 10. With this study, the investigators want to know if fractional CO2 laser can reduce the inflammatory process and symptoms in vulvar lichen sclerosus such as itching, and if this could be an alternative treatment for this condition.

Interventions

• Device Fractional microablative CO2 Laser
  In this study the investigators use the laser device without any topic esteroid previous or during the period of laser sessions

Primary outcome measures

• Evaluation and comparison of inflammatory biomarkers before and after treatment with clobetasol or CO2 laser. [Time frame: Each participant will be monitored from registration, throughout treatment, and up to three months after the end of treatment.]
• To evaluate the performance of CO2 laser in vulvar lichen sclerosus in relation to inflammatory skin markers and compare to clobetasol [Time frame: From enrollment to a second biopsy 3 months after treatment]

Eligibility criteria

Inclusion Criteria: Women older than 21 years; histological diagnostic of vulvar lichen sclerosus and no previous treatment with topic corticoesteroid

Exclusion Criteria: Women that don't agree in taking part of the study; other concomitant vulvar diseases; pre malignant vulvar disease HPV dependent and independent; previous pelvic radiotherapy

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Brazil · 1 center

• Institute of Gynecology of the Federal University of Rio de Janeiro — Rio de Janeiro

Publications

• Krause E, Neumann S, Maier M, Imboden S, Knabben L, Mueller MD, Kuhn A. LASER treatment in gynaecology -A randomized controlled trial in women with symptomatic lichen sclerosus. Eur J Obstet Gynecol Reprod Biol. 2023 Aug;287:171-175. doi: 10.1016/j.ejogrb.2023.06.003. Epub 2023 Jun 8. PMID 37352640
• Preti M, Vieira-Baptista P, Digesu GA, Bretschneider CE, Damaser M, Demirkesen O, Heller DS, Mangir N, Marchitelli C, Mourad S, Moyal-Barracco M, Peremateu S, Tailor V, Tarcan T, De EJB, Stockdale CK. The clinical role of LASER for vulvar and vaginal treatments in gynecology and female urology: An ICS/ISSVD best practice consensus document. Neurourol Urodyn. 2019 Mar;38(3):1009-1023. doi: 10.1002/ PMID 30742321
• Tasker F, Kirby L, Grindlay DJC, Lewis F, Simpson RC. Laser therapy for genital lichen sclerosus: A systematic review of the current evidence base. Skin Health Dis. 2021 Jun 15;1(3):e52. doi: 10.1002/ski2.52. eCollection 2021 Sep. PMID 35663131
• Burkett LS, Siddique M, Zeymo A, Brunn EA, Gutman RE, Park AJ, Iglesia CB. Clobetasol Compared With Fractionated Carbon Dioxide Laser for Lichen Sclerosus: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jun 1;137(6):968-978. doi: 10.1097/AOG.0000000000004332. PMID 33957642
• Filippini M, Sozzi J, Farinelli M, Verdelli A. Effects of Fractional CO2 Laser Treatment on Patients Affected by Vulvar Lichen Sclerosus: A Prospective Study. Photobiomodul Photomed Laser Surg. 2021 Dec;39(12):782-788. doi: 10.1089/photob.2021.0053. PMID 34878932
• Singh N, Ghatage P. Etiology, Clinical Features, and Diagnosis of Vulvar Lichen Sclerosus: A Scoping Review. Obstet Gynecol Int. 2020 Apr 21;2020:7480754. doi: 10.1155/2020/7480754. eCollection 2020. PMID 32373174
• Farrell AM, Dean D, Millard PR, Charnock FM, Wojnarowska F. Cytokine alterations in lichen sclerosus: an immunohistochemical study. Br J Dermatol. 2006 Nov;155(5):931-40. doi: 10.1111/j.1365-2133.2006.07414.x. PMID 17034521
• Krapf JM, Mitchell L, Holton MA, Goldstein AT. Vulvar Lichen Sclerosus: Current Perspectives. Int J Womens Health. 2020 Jan 15;12:11-20. doi: 10.2147/IJWH.S191200. eCollection 2020. PMID 32021489

Identifiers

NCT: NCT07240519 · 52132021000005275

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗