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2019年7月23日
适应症ail psoriasisMedDRA version: 20.0Level: HLTClassification code 10065874Term: Psoriatic conditionsSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 20.0Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 21.1Level: PTClassification code 10037162Term: Psoriatic arthropathySystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersMedDRA version: 20.0Level: PTClassification code 10028703Term: Nail psoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 22.0Level: LLTClassification code 10028691Term: Nail discolorationSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 21.1Level: LLTClassification code 10006373Term: Brittle nailsSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 20.0Level: LLTClassification code 10028689Term: Nail changesSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 20.0Level: LLTClassification code 10028690Term: Nail deformationSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 21.1Level: LLTClassification code 10049281Term: Nail lossSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 20.0Level: LLTClassification code 10064253Term: Nail painSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 21.1Level: LLTClassification code 10064768Term: Nail growth increasedSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 21.1Level: LLTClassification code 10065260Term: Splitting nailsSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 21.0Level: LLTClassification code 10069831Term: Broken nailsSyTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
相关药物Enstilar
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- ail psoriasis
- 发起方
- Merete Haedersdal [Bispebjerg Hospital]
- 入组人数
- 11
- 状态
- 进行中（未招募）
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
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.
结局指标
主要结局
未指定
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Assessing the Efficacy of Image-guided Laser-assisted Enstilar® Delivery for Treatment of Psoriatic NailsNail PsoriasisNCT04580537Bispebjerg Hospital11
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