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.

NCT07240519 | Recruiting

• 1 other identifier: 52132021000005275
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vulvar Lichen Sclerosus

Keywords

CO2 laser; vulvar lichen sclerosus

Outcome Measures

Primary Outcomes (2)

• Evaluation and comparison of inflammatory biomarkers before and after treatment with clobetasol or CO2 laser.

  Before and after each of the two treatments, a vulvar punch biopsy will be performed. The fragment will then be analyzed using immunohistochemistry to assess changes in inflammatory biomarkers.

  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

  In vulvar skin fragment obtained by punch biopsy, some inflammatory biomarkers such as TGF-β, INF-γ, VEGF, and IL-10 will be evaluated before and three months after the last laser session. The biomarkers will be quantified by immunohistochemistry at the Immunology and Immunogenetics Laboratory of Fiocruz. For the count, a compound optical microscope will be used, consisting of a 40x objective lens and a 10x grating eyepiece. The total number of cells positive for the marker being analyzed will be recorded in each field.

  From enrollment to a second biopsy 3 months after treatment

Study Arms (2)

Paricipants randomized for Clobetasol ointment group

ACTIVE COMPARATOR

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

Device: Fractional microablative CO2 Laser

Participants randomized for Fractional Carbon dioxide (CO2 ) laser group treatment

EXPERIMENTAL

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.

Device: Fractional microablative CO2 Laser

Interventions

Fractional microablative CO2 Laser DEVICE

In this study the investigators use the laser device without any topic esteroid previous or during the period of laser sessions

Paricipants randomized for Clobetasol ointment group; Participants randomized for Fractional Carbon dioxide (CO2 ) laser group treatment

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead

Study Sites (1)

Institute of Gynecology of the Federal University of Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, 20211 340, Brazil

RECRUITING

Related Publications (8)

• 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 RESULT

• 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.

  PMID: 30742321 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Vulvar Lichen Sclerosus

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Andrea Cytryn, Master of Science in Health

  Department of Gynecology, Institute of Gynecology, Federal University of Rio de janeiro

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andréa Cytryn, Master Degree

CONTACT

+55 21 98123 0332; andreacytryn@hotmail.com

Yara Lúcia M. Furtado de Melo, PhD in Surgical Sciences

CONTACT

+ 55 21 999826257; yarafurtadorj@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Forty women will be randomized after histological confirmation of vulvar lichen sclerosus for one of the two arms. 20 women will be allocated to clobetasol group and 20 women will be allocated to CO2 laser group

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 21, 2025
• Study Start: June 22, 2022
• Primary Completion: September 10, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data becomes available 6 months after publication.

Locations

BR (1)