An Open-label Study to Investigate the Effectiveness in Clinical Symptomatic Control and Tolerability of Medical Device LabiaStick#01 in Subjects With Symptomatic Non-hypertrophic Chronic Vulvar Dermatoses
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 12
- 主要终点
- Reduction on subject's vulvar pruritus score
研究概览
简要总结
The current study aims to investigate the effectiveness in clinical symptomatic control and tolerability of LabiaStick#01 in women with symptomatic non-hypertrophic chronic vulvar dermatoses.
详细描述
Vulvar dermatoses are skin disorders that affect the vulva, causing pruritus, irritation and pain. Although the prevalence of these disorders is unknown, it is well accepted that the vulvar symptoms are a common problem for women.
LabiaStick#01 has emollient agents whose main function is to increase the skin hydration, provide physical protection and decrease the symptoms and possibility of recurrence of vulvar dermatoses.
The medical device should be applied once daily, in the evening, after intimal hygiene care.
The primary objective of this study is to evaluate the effectiveness of LabiaStick#01 on the relief of pruritus caused by symptomatic non-hypertrophic chronic vulvar dermatoses.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Able and willing to give written informed consent.
- •Woman, with 18 or more years.
- •Diagnosed with symptomatic non-hypertrophic chronic vulvar dermatoses.
- •A pruritus score of at least 20 on a 100-mm VAS-PR.
- •Willing and able to comply with the study requirements.
- •Participant of childbearing potential agrees to remain abstinent or to use an acceptable contraceptive measure for the entire duration of the study.
- •Participant not of childbearing potential (e.g., is not sexually active, whose current partner is not of reproductive potential).
排除标准
- •Received systemic immunosuppressant therapy (e.g. systemic corticosteroids) within 4 weeks prior to admission.
- •Treated with daily topical therapy (e.g. topical corticosteroids, pimecrolimus, and tacrolimus) at the target vulvar area within 2 weeks prior to admission, which in the opinion of the investigator might compromise study results.
- •Immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have an uncontrolled malignant disease.
- •Suffers from systemic or generalized infections (bacterial, viral or fungal).
- •Diagnosis of psoriasis, candidiasis, vulvar intraepithelial neoplasia or carcinoma of the vulva.
- •Pregnancy or breastfeeding.
- •Documented and consistent history of hypersensitivity reactions to similar topical products.
- •Any condition that in the opinion of the investigator might prevent the subject from completing the study or interfere with the interpretation of the study results.
研究组 & 干预措施
LabiaStick#01
Each participant will have an at least 2-week baseline period followed by a 4-week treatment period with LabiaStick#01.
干预措施: LabiaStick#01 (Device)
结局指标
主要结局
Reduction on subject's vulvar pruritus score
时间窗: 14 days during run-in period and 14 days during treatment period
Reduction on subject's vulvar pruritus score assessed on a 100-mm Visual Analogue Scale for Pruritus Relief (VAS-PR) following once-daily application of LabiaStick#01, for 4 weeks.
次要结局
- Reduction on subject's vulvar burning sensation score(During 4 weeks)
- Clinical Global Impression of Change (CGI-C)(At Visit 3 (28 days after the end of baseline))
- Patient Global Impression of Change (PGI-C)(At Visit 3 (28 days after the end of baseline))
- Subjects' opinion on the acceptability of the medical device(At Visit 3 (28 days after the end of baseline))
- Adverse events(Up to 6 weeks)
- Need of rescue medication(Up to 6 weeks)