EUCTR2019-002960-29-DK进行中（未招募）1 期
Assessing the efficacy of image-guided laser-assisted Enstilar® delivery for treatment of psoriatic nails - a proof-of-concept, single-center, prospective, open-label, randomized, clinical trial with an intra-individual comparison of treatments - LAsED
Merete Haedersdal [Bispebjerg Hospital]0 个研究点目标入组 11 人开始时间: 2019年7月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 11
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Informed consent obtained before any trial-related activities.
- •2.At least 18 years of age (inclusive)
- •3.Confirmed diagnosis of psoriatic disease with signs of nail psoriasis* on at least 2 digits
- •4.Minimum nail involvement as assessed by treating physician (N-NAIL score of = 2 for at least two individual nails)
- •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 11
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Insufficient knowledge of written and spoken Danish.
- •2.Pregnant and lactating women and women who intend to become pregnant during the trial*
- •3.Pre-existing clinical manifestations of long-term side effects of corticosteroid use including but not limited to skin atrophy or telangiectasias on fingers
- •4.Presence of any skin condition or coloration (marked suntan, hyperpigmentation, smoking-induced staining, tattoos or body art) that would interfere with the evaluation of the clinical response in the test sites or assessment
- •5.Any non-psoriatic disease activity within test areas
- •6.Significant history or current evidence of chronic infectious disease, systemic disorders, or organ dysfunction where the use of Enstilar is contraindicated.
- •7.Known predisposition for hypertrophic scar formation.
- •8.Known allergy to any of the components of Enstilar®.
- •9.Current treatment with systemically or locally acting medications which might counter or influence the trial aim
- •10.Received any drug as part of a research trial within 30 days prior to initial trial dosing.
- •11.Artificial nail enhancement or damages associated with it, including (semi-) permanent nail polish e.g. acrylic based gels.
- •12.Ongoing fungal infections of psoriatic nails
- •13.Close affiliation with the investigator (e.g. a close relative) or persons working at the respective trial site or the participant is an employee of the sponsor
- •14.In the opinion of the investigator, the participant is unlikely to comply with the Clinical Trial Protocol (e.g. alcoholism, drug dependency or psychotic state).
研究者
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