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Recruitment was significantly impacted by the COVID-19 pandemic.
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| Name | Class |
|---|---|
| Sciton | INDUSTRY |
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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.
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.
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
Follow-up visit 2, month 6
Follow-up visit 6, month 9
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablative Fractional 2940 nm Laser | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to 3 months after the last laser treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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We are currently recruiting Massachusetts residents only due to COVID-19.
Inclusion Criteria:
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
Ability to complete questionnaires in English
Written, informed consent
Willing and able to logistically follow schedule of treatments and follow-up visits
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roger Lefevre, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BIDMC | Boston | Massachusetts | 02115 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | 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 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˚.
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| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
2 patients did not have the primary outcome assessed
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | 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 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˚.
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| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 2 patients did not have the primary outcome assessed |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Enrolled participants who had a post treatment biopsy | Posted | Median | Inter-Quartile Range | microns | From enrollment to 3 months after the last laser treatment |
|
Baseline to six months
Light spotting (bleeding from the area outside the vagina where the laser is used) Allergic reaction to topical anesthetic (numbing cream) Infection from the biopsy or the laser treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | 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 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˚.
|
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Light spotting | Reproductive system and breast disorders | Non-systematic Assessment | Bleeding from the area outside the vagina where the laser is used |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roger Lefevre | BIDMC | 6176674070 | rlefevre@bidmc.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 29, 2020 | Jul 14, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 13, 2021 | Feb 2, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D007724 | Vulvar Lichen Sclerosus |
| ID | Term |
|---|---|
| D014845 | Vulvar Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D007834 | Lasers |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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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.
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No masking will be used as all patients will receive the treatment.
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| 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 | 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 | 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 | 3 months after last laser treatment |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Self-reported sex collected on Study Questionnaire | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Baseline depth of lichen penetration | Baseline depth of penetration of Lichen sclerosus | Median | Inter-Quartile Range | Microns |
|
|
|
| Secondary | 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 | Posted | Median | Inter-Quartile Range | score on a scale | From enrollment to 3 months after last laser treatment |
|
|
|
| Secondary | 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 | Posted | Median | Inter-Quartile Range | score on a scale | 3 months after last laser treatment |
|
|
|
| Secondary | 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 | Posted | Median | Inter-Quartile Range | score on a scale | From enrollment to 3 months after last laser treatment |
|
|
|
| Secondary | 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 | Posted | Median | Inter-Quartile Range | score on a scale | 3 months after last laser treatment |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
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| Allergic reaction to topical anesthetic | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Infection from the biopsy or the laser treatment | Infections and infestations | Non-systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |