Clinical Study of the CO2RE® Laser Device for Treatment of Vulvar Lichen Sclerosus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 8
- 主要终点
- Average Scores for VLS Architectural Changes Present At Baseline and at 3, 6 and 12 Months After the Last Treatment as Assessed by the Investigators
研究概览
简要总结
Subjects with vulvar lichen sclerosus (VLS) will undergo fractional carbon dioxide (CO2) laser treatment to the vulvar area. Subjects will be evaluated for changes in clinical signs and architectural changes associated with VLS at designated follow-ups to 1-year post treatment series.
详细描述
This study is a prospective, non-randomized, single-group assignment, interventional clinical trial. Female subjects with vulvar lichen sclerosus (VLS) supported by histologic findings on biopsy and/or clinical signs on physical examination and recalcitrant to mid- to high-potency steroid therapy, will undergo up to 5 monthly treatments to the vulva with a fractional CO2 laser.
Investigators will assess clinical signs and architectural changes associated with VLS. Baseline measurements will be compared to follow-up at 6 weeks, 3 months, 6 months and 12 months after the final treatment.
Subjects will self report sexual function using a validated FSFI Questionnaire at baseline and at the 3- and 6-month follow-ups.
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
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Able to read, understand and sign informed consent for study participation;
- •Female subjects with age 18-80 years;
- •Biopsy demonstrates biopsy-proven lichen sclerosus and/or there are characteristic changes for vulvar lichen sclerosus on physical examination;
- •Treatment of LS has been recalcitrant to mid to high-potent topical corticosteroid treatment or subject refuses topical corticosteroid treatment. Recalcitrance to therapy is defined as no response to topical corticosteroids of an adequate potency (i.e. clobetasol propionate 0.05% ointment or other steroids) and a sufficient duration (12 weeks of use) or lack of symptomatic control of the disease with a maintenance therapy;
- •Topical corticosteroid treatment, if any, will be continued during the study period;
- •Exogenous hormone treatment, if any, will be continued during the study period (type and dose must stay consistent throughout the study);
- •One or more of the following symptoms: itch; pain unrelated to intercourse; pain, skin tearing or bleeding with intercourse; changes/decrease in sexual function;
- •No breaks, tears or lesions, malodorous discharge or strawberry cervix present on gynecological exam.
排除标准
- •Presence of clinically atypical appearing nevi in the area to be treated;
- •Unexplained vaginal bleeding;
- •Active infection, specifically: urinary tract infection, vulvar or vaginal infection (candidiasis, genital herpes/herpes simplex virus, bacterial vaginosis, trichomonas);
- •History of vulvar or any gynecological malignancy, as well as history of pelvic radiation therapy or stem cell transplant;
- •Pelvic organ prolapse > stage 2;
- •Pregnancy or planning pregnancy during the study;
- •Systemic treatment with immuno-modulatory drugs.
- •Use of vaginal dilators during study.
结局指标
主要结局
Average Scores for VLS Architectural Changes Present At Baseline and at 3, 6 and 12 Months After the Last Treatment as Assessed by the Investigators
时间窗: Baseline, 3 , 6 and 12 months after the final treatment
Each architectural change of VLS (labial fusion, clitoral hood fusion, narrowing of the introitus, anterior changes, perianal involvement, formation of posterior commissure bands) was assessed separately by the investigator, using a 4-point scale (0=not present, 1=mild, 2=moderate or 3=severe) for each subject at baseline and follow-ups. For those architectural changes present at baseline (baseline score \>0 on severity scale), an average severity grade was calculated at each endpoint to evaluate overall treatment outcome, as follows: Average severity grade = Sum of all severity grades (0, 1, 2, or 3) for each individual parameter of architectural changes present at baseline for each subject / Number of grades A lower average score means better outcome.
Average Scores for VLS Clinical Signs Present At Baseline, 3, 6 and 12 Months After the Last Treatment as Assessed by the Investigators
时间窗: At Baseline, 3, 6 and 12 months after the final treatment
Each clinical sign of VLS (loss of elasticity, sclerosis, lichenification, whitening, parchment-like skin, fissures, extent of the disease, erosions, ulcerations, hyperkeratosis, excoriation, telangiectasia) was assessed separately by the investigator, using a 4-point scale (0=not present, 1=mild, 2=moderate or 3=severe) for each subject at baseline and follow-ups. For those clinical signs present at baseline (baseline score \>0 on severity scale), an average severity grade was calculated at each endpoint to evaluate overall treatment outcome, as follows: Average severity grade = Sum of all severity grades (0, 1, 2, or 3) for each individual parameter of clinical signs present at baseline for each subject / Number of grades A lower average score means better outcome.
次要结局
- Subject Satisfaction At the 12-Month Follow-up(12 months after the final treatment)
- Change From Baseline in Sexual Function on the Female Sexual Function Index (FSFI) at 3 Months and 6 Months After the Final Treatment(Baseline and 3 months and 6 months after the final treatment)
- Treatment Associated Pain Score(Immediately after the 1st, 2nd, 3rd, 4th and 5th monthly treatments post baseline)