A Double Blind Placebo-controlled Trial of StrataMGT for the Management of Vulvar Lichen Sclerosus Symptoms.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Vulvar Quality of Life Index 11 (VQLI)
研究概览
简要总结
This study is designed to evaluate the efficacy and safety of StrataMGT for the management of vulvar lichen sclerosus symptoms.
详细描述
This will be a randomized double-blind placebo-controlled trial to evaluate the efficacy and safety of StrataMGT for the management of the symptoms of vulvar lichen sclerosus. Up to 100 patients with a diagnosis of biopsy proven vulvar lichen sclerosus will be recruited from two centers. This study will consist of a two-week screening period and a 12-week treatment period. At the beginning of the screening period, a vulvoscopy will be performed at the screening visit and after the 12-week treatment period to rule out vulvar intrepithelial neoplasia (VIN) or carcinoma. All eligible patients will be randomized to receive either placebo gel or treatments with the investigation product, StrataMGT TM 1:1 ratio.
The primary efficacy endpoint will be change in score on the Vulvar Quality of Life Index 11 (VQLI).
Secondary efficacy endpoints will be the Skindex 29, and the Clinical Lichen Sclerosus Scoring Scale (CLISSCO).
All adverse events will be recorded, including serious adverse events. A physical examination will be performed at each visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Female, 18 years or older.
- •With a diagnosis of biopsy proven vulvar lichen sclerosus.
- •Signed written informed consent.
- •Willingness and ability to comply with the study requirements.
- •Subject must have a score of 10 or greater in the VQLI at screening.
- •Must be on a stable regimen of topical corticosteroids or topical calcineurin inhibitor for at least 2 months prior to the screening visit.
- •Women currently on a stable regimen of intravaginal estrogen therapy for at least 2 months may remain on the estrogen therapy throughout the study.
- •Women currently using topical estrogen therapy on the vulva must stop two weeks prior to enrolling in the study.
- •Women must have a culture negative for candidiasis or bacterial vaginosis at screening.
排除标准
- •Who are immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have an uncontrolled malignant disease.
- •Who suffer from a topical or systemic infections (bacterial, viral or fungal) at the time of screening. Subjects who screen positive for either candidiasis or bacterial vaginosis at the screening visit may be treated and retested and may participate if the confirmatory test after treatment is negative. Any vulvovaginal infections during their participation in the study will be considered an adverse event. The subject will then stop the study IP and will be treated for the infection and may resume use of the IP 3 days after the last dose of medication for the infection. They will be discontinued from the study if they have two infections during the study.
- •Who have been diagnosed with lichen planus, psoriasis, intraepithelial neoplasia, or carcinoma of the vulva.
- •Who had received an investigational drug within four weeks prior to the study or who intend to use other investigational drugs during the course of this study.
- •Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study.
- •Who have a history of substance abuse or any factor, which limits the subject's ability to cooperate with the study procedures.
- •Who are uncooperative, known to miss appointments (according to subjects' records) and are unlikely to follow medical instructions or are not willing to attend regularly scheduled visits.
研究组 & 干预措施
Investigational product
StrataMGT® is a semi-permeable, non-resorbable and self-drying gel. StrataMGT® contains no steroids, hormones, alcohol, parabens or fragrances. StrataMGT® gel is bacteriostatic, inert, and is manufactured in compliance with good manufacturing practices (GMPs), 21CFR210 and 211.
干预措施: StrataMGT (Drug)
Placebo
This arm will be a sterile, transparent, water-soluble lubricating jelly that is not silicone-based.
干预措施: Placebo (Drug)
结局指标
主要结局
Vulvar Quality of Life Index 11 (VQLI)
时间窗: throughout the study, averaging 3.5 months
The VQLI is used to "assess symptomatic, psychosexual and physical aspects of vulvar disease" \[1\] using the following scale: Very Much, A Lot, A Little, and Not At All. The questionnaire consists of 15 questions.
次要结局
- Skindex 29(throughout the study, averaging 3.5 months)
- Clinical Scoring System for Vulvar Lichen Sclerosus(throughout the study, averaging 3.5 months)
研究者
Andrew T. Goldstein, MD
Principal Investigator
Center for Vulvovaginal Disorders