Effectiveness of Ablative Fractional 2940 nm Laser Treatment for Vulvar Lichen Sclerosus
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in Depth of Disease From Baseline to Three Months After the Last Laser Treatment
研究概览
简要总结
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.
详细描述
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˚.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking will be used as all patients will receive the treatment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •Blistering
- •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
排除标准
- •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
结局指标
主要结局
Change in Depth of Disease From Baseline to Three Months After the Last Laser Treatment
时间窗: 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.
次要结局
- Satisfaction With Treatment Using a Participant Satisfaction Questionnaire(3 months after last laser treatment)
- Change in Symptom Severity Using the Patient Global Impression Scale of Severity (PGIS)(From enrollment to 3 months after last laser treatment)
- Change in Symptoms and Quality of Life Using the Vulvovaginal Symptom Questionnaire (VSQ)(From enrollment to 3 months after last laser treatment)
- Change in Symptoms Using the Patient Global Impression Scale of Change (PGIC)(3 months after last laser treatment)
研究者
Roger Lefevre
Instructor in Obstetrics, Gynecology and Reproductive Biology
Beth Israel Deaconess Medical Center