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.
NCT ID: NCT07240519
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2022-06-22
2026-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Paricipants randomized for Clobetasol ointment group
Participants in this group will apply clobetasol propionate 0.05% ointment to the vulvar affected area in an amount sufficient to cover the finger tip according to standard treatment protocol:
every day in the first month every other day in the second month twice a week (for example: Mondays and Thursdays) in the third month
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
Participants randomized for Fractional Carbon dioxide (CO2 ) laser group treatment
Fractional microablative CO2 laser An anesthetic ointment provided by the principal investigator, applied on vulva skin, perineal area and vulvar vestibule 30 - 45 minutes before the Session of CO2 laser.
Three sessions spaced four weeks apart, with instructions after each session, such as avoiding sexual intercourse for five days and using a product like petroleum jelly for relief for a few days.
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
Interventions
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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
Eligibility Criteria
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Exclusion Criteria
21 Years
FEMALE
No
Sponsors
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Universidade Federal do Rio de Janeiro
OTHER
Responsible Party
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Andréa Cytryn
Principal investigator
Principal Investigators
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Andrea Cytryn, Master of Science in Health
Role: PRINCIPAL_INVESTIGATOR
Department of Gynecology, Institute of Gynecology, Federal University of Rio de janeiro
Locations
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Institute of Gynecology of the Federal University of Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, Brazil
Countries
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Central Contacts
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Yara Lúcia M. Furtado de Melo, PhD in Surgical Sciences
Role: CONTACT
Facility Contacts
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References
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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.
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/nau.23931. Epub 2019 Feb 11.
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.
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.
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.
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.
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.
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.
Related Links
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Related Info
Other Identifiers
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52132021000005275
Identifier Type: -
Identifier Source: org_study_id
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