Vulvar Lichen SclerosusLASERNCT07240519
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.
A study testing Fractional microablative CO2 Laser in people with Vulvar Lichen Sclerosus, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Vulvar Lichen Sclerosus
- What is being tested?
- Fractional microablative CO2 Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 22 Jun 2022to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yara Lúcia M. Furtado de Melo, PhD in Surgical Sciences contact
Brazil1 site, 1 recruiting
- Recruiting
Institute of Gynecology of the Federal University of Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 20211 340
Yara Lúcia M Furtado de Melo, PhD, + 55 21 99982 6257, yarafurtadorj@gmail.com
Yara Lúcia M Furtado de Melo, PhD
About this study
Official title: 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.
- Conditions
- Vulvar Lichen Sclerosus
- Being tested
- Fractional microablative CO2 Laser
- Keywords
- CO2 laser, vulvar lichen sclerosus
- Medical subject headings
- Vulvar Lichen Sclerosus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional microablative CO2 LaserDevice
In this study the investigators use the laser device without any topic esteroid previous or during the period of laser sessions
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Fractional microablative CO2 Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment to a second biopsy 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start22 Jun 2022
- Primary completion10 Sep 2025
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Vulvar Lichen SclerosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andréa Cytryn, Universidade Federal do Rio de Janeiro
- Investigators
- Andrea Cytryn, Master of Science in Health, Principal investigator, Department of Gynecology, Institute of Gynecology, Federal University of Rio de janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240519
- Sponsor's protocol ID
- 52132021000005275
- Acronym
- LASER
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
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.
PubMed 37352640Preti 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.
PubMed 30742321Tasker 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.
PubMed 35663131Burkett 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.
PubMed 33957642Filippini 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.
PubMed 34878932Singh 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.
PubMed 32373174Farrell 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.
PubMed 17034521Krapf 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.
PubMed 32021489
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vulvar Lichen Sclerosus: Expression of Inflammatory Markers in a Randomized Clinical Trial With Clobetasol Versus Laser
- ClinicalTrials.gov ID
- NCT07240519
- Acronym / sponsor ID
- LASER / 52132021000005275
- Conditions
- Vulvar Lichen Sclerosus
- Keywords
- CO2 laser, vulvar lichen sclerosus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- Jun 2026 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Paricipants randomized for Clobetasol ointment group | Active comparator | Device: Fractional microablative CO2 LaserParticipants 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 |
| Participants randomized for Fractional Carbon dioxide (CO2 ) laser group treatment | Experimental | Device: Fractional microablative CO2 LaserFractional 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fractional microablative CO2 LaserIn this study the investigators use the laser device without any topic esteroid previous or during the period of laser sessions | Device | Paricipants randomized for Clobetasol ointment group, Participants randomized for Fractional Carbon dioxide (CO2 ) laser group treatment |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Results publication: PubMed 37352640Krause 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.
- Results publication: PubMed 30742321Preti 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.
- Results publication: PubMed 35663131Tasker 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.
- Results publication: PubMed 33957642Burkett 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.
- Results publication: PubMed 34878932Filippini 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.
- Results publication: PubMed 32373174Singh 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.
- Results publication: PubMed 17034521Farrell 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.
- Results publication: PubMed 32021489Krapf 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 InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yara Lúcia M. Furtado de Melo, PhD in Surgical Sciences contact
Andrea Cytryn, Master of Science in Health principal investigator
Department of Gynecology, Institute of Gynecology, Federal University of Rio de janeiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractional microablative CO2 Laser in people with Vulvar Lichen Sclerosus, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andréa Cytryn, Master Degree (+55 21 98123 0332, andreacytryn@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07240519, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.