NCT02854670终止2 期
A Study of the Effects of Topical Capsaicin in the Treatment of Provoked Vestibulodynia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Pain assessment with Visual Analogic Scale (using a q-tip)
研究概览
简要总结
This study aims to assess the pain on contact in provoked vestibulodynia, measured with Visual Analogic Scale at week 0/week 2/week 6/week 12 after applying a patch of capsaicin.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Provoked vulvodynia, rated B2a according to 2003 International Society for the Study of Vulvovaginal Disease (ISSVD) classification
- •Pain ≥ 4 on Visual Analogic Scale (VAS)
- •Subject refractory to at least 2 conventional treatments (tricyclic antidepressants, anticonvulsants at analgesic doses , biofeedback physical therapy, psychological assessment in a context of chronic pain) or to botulinum toxin A
- •If a former treatment with botulinum toxin A was performed: patient must be in treatment failure (= no decrease over 50% of the pain 3 months after initiation of the treatment)
- •Negative screening test results
- •Menopause, surgically sterilized women or women using effective contraceptive method
- •Good understanding and predictable adherence to the protocol
- •Beneficiary/affiliated to French social security/social healthcare
- •Signed Informed Consent Form
排除标准
- •Predictable poor adherence
- •Pregnant or breastfeeding women
- •Diabetes mellitus type 1 or type 2
- •Major mental disorders
- •Underlying etiology such as chronic vulvar disease
- •Initial vulvar erythema
- •Vulnerable subjects (particularly adults under guardianship)
- •Ongoing medical treatment with tricyclic antidepressants or anticonvulsants at analgesic doses
- •Subject refractory to conventional treatments (tricyclic antidepressants and benzodiazepines doses analgesics, physiotherapy type of biofeedback)
- •Good understanding and predictable adherence to the protocol beneficiary/affiliated to French social security/social healthcare signed Informed Consent Form
研究组 & 干预措施
Capsaicin patch
Experimental
Cuttable capsaicin patch. 2 patches of 4 cm² (2 x 2cm), for a total of 2.5 mg of capsaicin.
干预措施: Capsaicin patch (Drug)
结局指标
主要结局
Pain assessment with Visual Analogic Scale (using a q-tip)
时间窗: week 12
Assessment of provoked pain with Visual Analogic Scale (using a q-tip)
次要结局
未报告次要终点
研究者
研究点 (1)
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