EUCTR2013-000410-38-DE进行中（未招募）1 期
Topical Aprepitant in Prurigo Patients (iTAPP)An exploratory phase IIa trial with topically applied aprepitant in patients with prurigo - Topical Aprepitant in Prurigo Patients (iTAPP)
EO Pharma A/S0 个研究点目标入组 20 人开始时间: 2013年8月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
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
- •-Signed informed consent has been obtained
- •-Patient with Prurigo suffering from chronic pruritus.
- •-Disease duration > six month
- •-Patients with symmetrical prurigo lesions at upper extremities (both arms) or lower extremities (both legs)
- •-Pruritus VAS greater than 6/10 two days before Visit 1 (Screening).
- •-Therapy refractory to at least two previous antipruritic treatments with topical, intralesional or systemic corticosteroids, or other immunosuppressant, antihistamines, antipsychotics, antidepressants, anticonvulsants and/or UV-irradiation.
- •-Patients need to agree to apply the IMP in accordance with the study protocol. An emollient cream (DAC Basiscreme) serves as rescue medication, which can be applied as often as desired at all body areas.
- •-Adult male or female patients, aged 18 to 80 years.
- •-Patients will be recruited from inpatient clinic as well as from outpatient clinic.
- •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 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •- Concomitant medications that are primarily metabolized through CYP3A4
- •- Applied topical antihistamines, corticosteroids or mast cell stabilizers to the skin less than 3 weeks prior to Visit 1 (Screening) or during the course of the trial.
- •- UV-irradiation during the last 6 weeks prior to the Visit 1 (Screening).
- •- Prescribed systemic medications like antihistamines, antidepressants, antipsychotics, corticosteroids are allowed if:
- •a. medication was taken at least 4 weeks prior to the trial and
- •b. no changes were made concerning the intake or dosage during the last 4 weeks and during the course of the trial.
- •- Clinically significant abnormalities in Blood analyses
- •- Marked hair density that will interfere with the absorption of IMP in treated areas
- •- Anamnestic excessive use of alcohol or tobacco or drugs
- •- Presence of active tumor disease or history of malignancies within five years prior to Visit 1 other than a successfully treated non-metastatic cutaneous, basal, or squamous cell carcinoma and/or in situ cancer.
- •- Known or suspected hypersensitivity to component(s) of investigational products.
- •- Within the last 30 days or current participation in any other interventional clinical trial
- •- Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the last 6 month.
- •- Previously enrolled/randomised in this clinical trial.
- •- In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g., alcoholism, drug dependency or psychotic state).
- •- Females who are pregnant, of child-bearing potential and wishing to become pregnant during the trial or are breast feeding.
- •- Females of child-bearing potential with positive pregnancy test.
- •- Subjects (or their partner) not using an adequate method of contraception (according to national requirements, as applicable)
研究者
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