EUCTR2021-001826-23-IT招募中1 期
A prospective, non controlled, phase 2 pilot study to assess the safety and efficacy of a new topical formulation of clobetasol 0.05% for mucosal use in patients with mucous membrane pemphigoid - Topical clobetasol for patients with mucous membrane pemphigoid
Dipartimento di Scienze della Salute dell'Università degli Studi di Firenze0 个研究点目标入组 10 人开始时间: 2022年10月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •- Male and female from 18 to 90 years old
- •- Clinical and immunopathological diagnosis of mucous membrane pemphigoid with active lesions on oral mucosa
- •- Dental hygiene treatment before the beginning of the study
- •- Stable disease activity: stable immunosuppressive therapy in the last 8 weeks and/or stable systemic steroids therapy (prednisone or comparable steroid) 10 mg/die or lower
- •- Ability to comprehend all the clinical criteria, to give informed consent and to perform all the clinical procedure
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 3
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •- Under 18 years of age or over 90
- •- Modification in immunosuppressive treatments in the last 8 weeks before the beginning of the study
- •- Treatment with rituximab in the 6 moths before the study
- •- Hypersesitivity to clobetasol
- •- Pregnancy of brestfeeding or women planning a pregnancy
- •- Partecipation to other clinical trial in the 3 moths before the beginning of the study
研究者
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