NCT06132919已完成2 期
A Parallel Group (2-arm), Randomised, Double-blind, 12-week Trial to Explore the Efficacy and Safety of MC2-25 Cream and MC2-25 Vehicle in Women Diagnosed With Vulvar Lichen Sclerosus (VLS)
MC2 Therapeutics1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2023年10月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Mean Change in Weekly Mean Worst Itch Numeric Rating Score (WI-NRS)
研究概览
简要总结
The purpose of this study is to explore the efficacy and safety of MC2-25 cream and MC2-25 vehicle in women with vulvar lichen schelosus (VLS).
详细描述
In this study, subjects who fulfil all inclusion and exclusion criteria are enrolled.
Eligible subjects will be randomized in a 1:1 ratio to MC2-25 cream or MC2-25 vehicle, respectively.
The subjects will apply the assigned investigational medicinal product (IMP) daily for 12 weeks.
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
- Triple (Participant, 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
- •Women, of any race or ethnicity, who are ≥18 years of age at the time of screening.
- •Able to understand the trial and willing to comply with trial requirements.
- •Has provided written informed consent.
- •Clinical diagnosis of VLS.
- •Presence of at least one of the following signs of VLS: Hyperkeratosis and/or Sclerosis.
- •First symptoms of VLS noticed by the patient at least 6 months before baseline.
- •At least four WI-NRS scores available in the diary for calculation of the average WI-NRS at the baseline visit.
- •At least moderate itch defined as average WI-NRS ≥4 at the Baseline visit.
- •Women must be of either of non-childbearing potential or childbearing potential with a negativ urine pregnancy test at baseline.
- •Women of childbearing potential must agree to use a highly effective method of contraception.
排除标准
- •Pregnant, breast feeding, or planning to become pregnant during the trial.
- •Any (other than VLS) ongoing localized or systemic disease involving the vulvar region.
- •Ongoing symptomatic Urinary Tract Infection.
- •Ongoing or prior diagnosis of any genitoanal malignancy or pre-malignancy.
- •Any kind of ongoing cancer prior to the Baseline visit.
- •Any chronic or acute systemic medical condition that, in the opinion of the investigator, may pose a risk to the safety of the patient or may interfere with the assessment of efficacy in this trial.
- •Known history of allergic reaction to any ingredients in MC2-25 cream or MC2-25 vehicle.
- •Start of a new or change of existing non-biologic systemic treatment, within 21 days prior to the Baseline visit.
- •Start of a new or change of existing biologic systemic treatment, within 3 months or 5 half-lives (whichever is longest) prior to the Baseline visit.
- •Start of a new or change of existing systemic or intravaginal treatment with estrogen containing products, within 21 days prior to the Baseline visit.
- •Start of new or change of menstrual care routines within 21 days prior to the Baseline visit.
- •Use of emollients on the vulvar region within 3 days prior to the Baseline visit.
- •Use of any topical treatment on the vulvar region, within 14 days prior to the Baseline visit.
- •Use of any light therapy on the vulvar region, within 28 days prior to the Baseline visit.
- •Received a non-marketed or blinded drug within 28 days or 5 half-lives (whichever is longer) prior to the Baseline visit.
- •If in the opinion of the investigator, the patient is unlikely to comply with the clinical trial protocol.
- •If previously randomized in this trial.
研究组 & 干预措施
MC2-25 cream
Experimental
MC2-25 cream will be applied daily for 12 weeks
干预措施: MC2-25 cream (Drug)
MC2-25-vehicle
Experimental
MC2-25 vehicle will be applied daily for 12 weeks
干预措施: MC2-25 vehicle (Drug)
结局指标
主要结局
Mean Change in Weekly Mean Worst Itch Numeric Rating Score (WI-NRS)
时间窗: 12 weeks
Mean change in weekly Worst Itch Numeric Rating score WI-NRS (as measured on a 11-point numeric rating scale from 0 - 10, where 0 represents no itch and 10 represents worst imaginal itch), calculated as the average of weekly means WI-NRS values from Baseline to Week 12 for MC2-25 cream compared to MC2-25 vehicle.
次要结局
未报告次要终点
研究者
研究点 (1)
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