Vulvar Lichen SclerosusNCT04134494
Laser Treatment for Vulvar Lichen Sclerosus
A study testing Ablative Fractional 2940 nm Laser in people with Vulvar Lichen Sclerosus, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The object of this non-randomized, prospective study is to assess the effectiveness of ablative fractional 2940 nm laser treatment of vulvar lichen sclerosus. Aim 1: To assess physical and histological changes related to vulvar lichen sclerosus before and after laser treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvar Lichen Sclerosus
- What is being tested?
- Ablative Fractional 2940 nm Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Aged 18 years old or older
- Biopsy-proven active vulvar lichen sclerosus
- Characteristic changes of vulvar lichen sclerosus on gynecological exam
- Self-reported indication of one or more of the following symptoms of lichen sclerosus
- Dryness
Show all 18Show fewer
- Itching
- Burning
- Bleeding
- Blistering
- Soreness
- Easily bruises
- Easily tears
- Ulcerated lesions
- Painful intercourse
- Ability to complete questionnaires in English
- Written, informed consent
- Willing and able to logistically follow schedule of treatments and follow-up visits
Who cannot join
- Receiving systemic immunosuppressant's (e.g. corticosteroids) within 4 weeks of enrollment
- Use of topical vulvar steroid-containing creams at the affected area within 4 weeks of enrollment
- Immunocompromised (e.g. lymphoma, AIDS, Wiskott-Aldrich syndrome)
- History of uncontrolled malignant disease
- Additional genital skin disease
- Known allergy or intolerance to topical anesthesia
- Known history of connective tissue disease
- Known propensity for keloid formations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Ablative Fractional 2940 nm Laser Treatment for Vulvar Lichen Sclerosus
The object of this non-randomized, prospective study is to assess the effectiveness of ablative fractional 2940 nm laser treatment of vulvar lichen sclerosus.
Aim 1: To assess physical and histological changes related to vulvar lichen sclerosus before and after laser treatment.
Aim 2: To evaluate participant satisfaction for laser treatment of vulvar lichen sclerosus.
The results of this study will determine whether fractional 2940 nm laser is an effective treatment option for lichen sclerosus, particularly for those participants not eligible for high-dose topical steroids or who have failed prior treatment with topical steroids.
Read the detailed description
This will be a non-randomized, open-label, prospective study. Participants will be recruited in general and subspecialty obstetrics and gynecology clinics. Participants who meet all eligibility criteria, including providing written informed consent, will have three treatment visits and three follow-up visits in an outpatient setting. Participants will not be charged for any treatments.
At each treatment visit, participants will be asked to complete questionnaires to assess their symptoms. The investigators will also take photographs of the affected area at each treatment visit. Photographs will include only the area of lichen sclerosus, such that individuals cannot be identified in the photographs. Participant photographs will be taken using the BIDMC PhotoConsult iOS application that allows providers to upload photographs to a patient's online medical record through a secure application.
Women with biopsy-proven lichen sclerosus will be treated with the ProFractional hand piece using the sapphire plate stand-off (Sciton, Inc. Palo, Alto, CA). The laser energy is delivered in a scanning fractional pattern to ablate microchannels in tissue to allow faster healing. Treatment will be delivered in 3 sessions scheduled 4 weeks (+/- 1 week) apart.
Prior to receiving treatment, topical 4% lidocaine anesthetic will be applied to the affected area for 20-30 minutes and then wiped away. The treatment area will be cleaned and dried of any moisture prior to treatment. The disinfected standoff with sapphire plate will then be applied to the ProFractional hand piece. Based on the biopsy results, the appropriate ablation depth will be inputted with 11% treatment density selected. Each treatment will include two passes of the laser over the affected area.
- Treatment visit 1, month 0: On the first pass, the depth of the laser will be from 300 to 500 microns, or the thickness of 3 to 5 sheets of paper; the depth will be based on the biopsy that was used to diagnosis the lichen sclerosus. On the second pass, the depth will be 50 microns deeper than the first pass and the hand piece rotated 45˚.
- Treatment visit 2, month 1: The first pass of the laser will be the same depth as the second pass from the last visit. The second pass will be 50 microns deeper and the hand piece rotated 45˚.
- Treatment visit 3, month 2: The first pass of the laser will be the same depth as the second pass from the last visit. The second pass will be 50 microns deeper and the hand piece rotated 45˚.
Participants will return for follow-up visits at 1, 3, and 6 months (months 3, 6 and 9 of the study) following the third treatment.
- Follow-up visit 1, month 3
- Participants will be asked to complete questionnaires to assess outcomes.
- The investigators will take photographs of the affected area.
- Follow-up visit 2, month 6
- Participants will be asked to complete questionnaires to assess outcomes.
- The investigators will take photographs of the affected area.
- Biopsy of area with lichen sclerosus; the biopsy will be done the same way as the one that was done to diagnosis your lichen sclerosus
- Follow-up visit 6, month 9
- Participants will be asked to complete questionnaires to assess outcomes.
- The investigators will take photographs of the affected area.
- Conditions
- Vulvar Lichen Sclerosus
- Being tested
- Ablative Fractional 2940 nm Laser
- Keywords
- Massachusetts residents
- 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.
Ablative Fractional 2940 nm LaserDevice
- Treatment visit 1, month 0: On the first pass, the depth of the laser will be from 300 to 500 microns, or the thickness of 3 to 5 sheets of paper; the depth will be based on the biopsy that was used to diagnosis the lichen sclerosus. On the second pass, the depth will be 50 microns deeper than the first pass and the hand piece rotated 45˚.
- Treatment visit 2, month 1: The first pass of the laser will be the same depth as the second pass from the last visit. The second pass will be 50 microns deeper and the hand piece rotated 45˚.
- Treatment visit 3, month 2: The first pass of the laser will be the same depth as the second pass from the last visit. The second pass will be 50 microns deeper and the hand piece rotated 45˚.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Women with biopsy-proven lichen sclerosus will be treated with the ProFractional hand piece using the sapphire plate stand-off (Sciton, Inc. Palo, Alto, CA). The laser energy is delivered in a scanning fractional pattern to ablate microchannels in tissue to allow faster healing. Treatment will be delivered in 3 sessions scheduled 4 weeks (+/- 1 week) apart Receives: Device: Ablative Fractional 2940 nm Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depth of Disease From Baseline to Three Months After the Last Laser Treatment
The baseline depth of lichen sclerosus will be based on the results of the clinical biopsy performed before study participation. The investigators will use the study biopsy collected at the follow-up visit three months after the last treatment to determine resolution of disease or, if disease persists, to what depth. The biopsies will therefore serve as an objective means to determine effective treatment of disease.
Measured: From enrollment to 3 months after the last laser treatment
Secondary outcomes (4)
Change in Symptoms and Quality of Life Using the Vulvovaginal Symptom Questionnaire (VSQ)
The VSQ is a 21-item written questionnaire with four scales: symptoms, emotions, life-impact, and sexual impact. Each item is assessed with yes or no questions. If a participant answers no, they receive a score of 0, and if the participant answers yes, they receive a score of 1 for each question. The results are added to a composite score.
Minimum score (better outcome): 0 Maximum score (worse outcome): 21
Measured: From enrollment to 3 months after last laser treatment
Change in Symptoms Using the Patient Global Impression Scale of Change (PGIC)
The PGIC is a written questionnaire to assess change in status or symptoms over time. Patients can say that their symptoms are: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6) or very much worse (7).
Minimum score (better outcome): 1 Maximum score (worse outcome): 7
Measured: 3 months after last laser treatment
Change in Symptom Severity Using the Patient Global Impression Scale of Severity (PGIS)
The PGIs is a written questionnaire to assess current status or symptoms. Patients can say that their symptoms are: normal (1), mild (2), moderate (3), or severe (4).
Minimum score (better outcome): 1 Maximum score (worse outcome): 4
Measured: From enrollment to 3 months after last laser treatment
Satisfaction With Treatment Using a Participant Satisfaction Questionnaire
Using a written questionnaire, patients will be asked how satisfied they were with the treatment. They can choose that they are extremely satisfied (1), somewhat satisfied (2), neither satisfied nor dissatisfied (3), somewhat dissatisfied (4), or extremely dissatisfied (5).
Minimum score (better outcome): 1 Maximum score (worse outcome): 5
Measured: 3 months after last laser treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start1 Jan 2020
- Primary completion27 May 2022
- Study completion31 Dec 2022
Why it stopped: Recruitment was significantly impacted by the COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vulvar Lichen SclerosusStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- The objective was to enroll a single group of 30 patients with biopsy-proven Lichen sclerosus will be treated on a monthly basis for 3 months. Biopsy to be repeated at month #6. The biopsy from before treatment will be compared with biopsies after treatment. Enrollment ended early.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sciton
- Responsible party
- Principal investigator, Roger Lefevre, Beth Israel Deaconess Medical Center
- Investigators
- Roger Lefevre, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134494
- Sponsor's protocol ID
- 2019P000344
- Status last verified
- May 2024
- First submitted
- 17 Oct 2019
- Last updated
- 5 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Ablative Fractional 2940 nm Laser Treatment for Vulvar Lichen Sclerosus
- ClinicalTrials.gov ID
- NCT04134494
- Acronym / sponsor ID
- 2019P000344
- Conditions
- Vulvar Lichen Sclerosus
- Keywords
- Massachusetts residents
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment was significantly impacted by the COVID-19 pandemic.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Sciton
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 27 May 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 22 Oct 2019 (actual)
- Results
- Posted 5 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The object of this non-randomized, prospective study is to assess the effectiveness of ablative fractional 2940 nm laser treatment of vulvar lichen sclerosus.
Aim 1: To assess physical and histological changes related to vulvar lichen sclerosus before and after laser treatment.
Aim 2: To evaluate participant satisfaction for laser treatment of vulvar lichen sclerosus.
The results of this study will determine whether fractional 2940 nm laser is an effective treatment option for lichen sclerosus, particularly for those participants not eligible for high-dose topical steroids or who have failed prior treatment with topical steroids.
Detailed description
This will be a non-randomized, open-label, prospective study. Participants will be recruited in general and subspecialty obstetrics and gynecology clinics. Participants who meet all eligibility criteria, including providing written informed consent, will have three treatment visits and three follow-up visits in an outpatient setting. Participants will not be charged for any treatments.
At each treatment visit, participants will be asked to complete questionnaires to assess their symptoms. The investigators will also take photographs of the affected area at each treatment visit. Photographs will include only the area of lichen sclerosus, such that individuals cannot be identified in the photographs. Participant photographs will be taken using the BIDMC PhotoConsult iOS application that allows providers to upload photographs to a patient's online medical record through a secure application.
Women with biopsy-proven lichen sclerosus will be treated with the ProFractional hand piece using the sapphire plate stand-off (Sciton, Inc. Palo, Alto, CA). The laser energy is delivered in a scanning fractional pattern to ablate microchannels in tissue to allow faster healing. Treatment will be delivered in 3 sessions scheduled 4 weeks (+/- 1 week) apart.
Prior to receiving treatment, topical 4% lidocaine anesthetic will be applied to the affected area for 20-30 minutes and then wiped away. The treatment area will be cleaned and dried of any moisture prior to treatment. The disinfected standoff with sapphire plate will then be applied to the ProFractional hand piece. Based on the biopsy results, the appropriate ablation depth will be inputted with 11% treatment density selected. Each treatment will include two passes of the laser over the affected area.
- Treatment visit 1, month 0: On the first pass, the depth of the laser will be from 300 to 500 microns, or the thickness of 3 to 5 sheets of paper; the depth will be based on the biopsy that was used to diagnosis the lichen sclerosus. On the second pass, the depth will be 50 microns deeper than the first pass and the hand piece rotated 45˚.
- Treatment visit 2, month 1: The first pass of the laser will be the same depth as the second pass from the last visit. The second pass will be 50 microns deeper and the hand piece rotated 45˚.
- Treatment visit 3, month 2: The first pass of the laser will be the same depth as the second pass from the last visit. The second pass will be 50 microns deeper and the hand piece rotated 45˚.
Participants will return for follow-up visits at 1, 3, and 6 months (months 3, 6 and 9 of the study) following the third treatment.
- Follow-up visit 1, month 3
- Participants will be asked to complete questionnaires to assess outcomes.
- The investigators will take photographs of the affected area.
- Follow-up visit 2, month 6
- Participants will be asked to complete questionnaires to assess outcomes.
- The investigators will take photographs of the affected area.
- Biopsy of area with lichen sclerosus; the biopsy will be done the same way as the one that was done to diagnosis your lichen sclerosus
- Follow-up visit 6, month 9
- Participants will be asked to complete questionnaires to assess outcomes.
- The investigators will take photographs of the affected area.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The objective was to enroll a single group of 30 patients with biopsy-proven Lichen sclerosus will be treated on a monthly basis for 3 months. Biopsy to be repeated at month #6. The biopsy from before treatment will be compared with biopsies after treatment. Enrollment ended early.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Ablative Fractional 2940 nm LaserWomen with biopsy-proven lichen sclerosus will be treated with the ProFractional hand piece using the sapphire plate stand-off (Sciton, Inc. Palo, Alto, CA). The laser energy is delivered in a scanning fractional pattern to ablate microchannels in tissue to allow faster healing. Treatment will be delivered in 3 sessions scheduled 4 weeks (+/- 1 week) apart |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Female
- Aged 18 years old or older
- Biopsy-proven active vulvar lichen sclerosus
- Characteristic changes of vulvar lichen sclerosus on gynecological exam
- Self-reported indication of one or more of the following symptoms of lichen sclerosus
Key exclusion criteria (8 listed)
- Receiving systemic immunosuppressant's (e.g. corticosteroids) within 4 weeks of enrollment
- Use of topical vulvar steroid-containing creams at the affected area within 4 weeks of enrollment
- Immunocompromised (e.g. lymphoma, AIDS, Wiskott-Aldrich syndrome)
- History of uncontrolled malignant disease
- Additional genital skin disease
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 |
|---|---|---|
| Ablative Fractional 2940 nm Laser* Treatment visit 1, month 0: On the first pass, the depth of the laser will be from 300 to 500 microns, or the thickness of 3 to 5 sheets of paper; the depth will be based on the biopsy that was used to diagnosis the lichen sclerosus. On the second pass, the depth will be 50 microns deeper than the first pass and the hand piece rotated 45˚. * Treatment visit 2, month 1: The first pass of the laser will be the same depth as the second pass from the last visit. The second pass will be 50 microns deeper and the hand piece rotated 45˚. * Treatment visit 3, month 2: The first pass of the laser will be the same depth as the second pass from the last visit. The second pass will be 50 microns deeper and the hand piece rotated 45˚. | Device | Intervention |
Primary outcome
Change in Depth of Disease From Baseline to Three Months After the Last Laser Treatment
Time frame: From enrollment to 3 months after the last laser treatment
The baseline depth of lichen sclerosus will be based on the results of the clinical biopsy performed before study participation. The investigators will use the study biopsy collected at the follow-up visit three months after the last treatment to determine resolution of disease or, if disease persists, to what depth. The biopsies will therefore serve as an objective means to determine effective treatment of disease.
4 secondary outcomes
Change in Symptoms and Quality of Life Using the Vulvovaginal Symptom Questionnaire (VSQ)
Time frame: From enrollment to 3 months after last laser treatment
Change in Symptoms Using the Patient Global Impression Scale of Change (PGIC)
Time frame: 3 months after last laser treatment
Change in Symptom Severity Using the Patient Global Impression Scale of Severity (PGIS)
Time frame: From enrollment to 3 months after last laser treatment
Satisfaction With Treatment Using a Participant Satisfaction Questionnaire
Time frame: 3 months after last laser treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Roger Lefevre, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablative Fractional 2940 nm Laser in people with Vulvar Lichen Sclerosus, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 8 exclusion criteria. 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: stopped early, as of the sponsor's last update on 5 Jun 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 5 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depth of Disease From Baseline to Three Months After the Last Laser Treatment (time frame: From enrollment to 3 months after the last laser treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2024.