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. (LASER)

November 20, 2025 updated by: Andréa Cytryn, Universidade Federal do Rio de Janeiro

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Yara Lúcia M. Furtado de Melo, PhD in Surgical Sciences
  • Phone Number: + 55 21 999826257
  • Email: yarafurtadorj@gmail.com

Study Locations

  • Brazil
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brazil, 20211 340
        • Recruiting
        • Institute of Gynecology of the Federal University of Rio de Janeiro
        • Contact:
        • Sub-Investigator:
          • Yara Lúcia M Furtado de Melo, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
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
Experimental: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Time Frame: From enrollment to a second biopsy 3 months after treatment

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Rio de Janeiro

Investigators

  • Principal Investigator: Andrea Cytryn, Master of Science in Health, Department of Gynecology, Institute of Gynecology, Federal University of Rio de janeiro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2022

Primary Completion (Actual)

September 10, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

November 16, 2025

First Submitted That Met QC Criteria

November 16, 2025

First Posted (Estimated)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 52132021000005275

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Sociodemographic data such as age, race, marital status, education. Clnical data such as parity, mode of delivery, active or inactive sexual life, period of reproductive life and current contraception, presence of autoimmune diseases, comorbidities such as hypertension, diabetes, regular medications and smoking

IPD Sharing Time Frame

Data becomes available 6 months after publication.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vulvar Lichen Sclerosus

Clinical Trials on Fractional microablative CO2 Laser

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe