EUCTR2018-003845-40-PL进行中（未招募）1 期
An open label evaluation of the adrenal suppression potential and pharmacokinetic properties of twice daily halobetasol propionate foam, 0.05% in subjects 12 to less than 18 years of age with plaque psoriasis receiving two weeks of treatment
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 25
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. Subject is male or non-pregnant female and is 12 to less than 18 years of age (i.e., at least 12 years old, but not yet reached their 18th birthday at the time of enrollment).
- •2. Subject has provided written informed assent and was accompanied by the parent or legal guardian at the time of assent/consent signing. The parent or legal guardian has provided informed consent for the subject. If a subject becomes 18 years of age during the study, the subject must provide written informed consent at the next study visit to continue study participation.
- •3. Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 10% BSA (excluding the face, scalp, groin, axillae and other intertriginous areas).
- •4. Subject has an Investigator’s Global Assessment (IGA) score of at least three (3 = moderate) at the Baseline Visit.
- •5. Subject is willing and able to apply the test article as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
- •6. Females must have a negative urine pregnancy test (UPT) at the Screening (Part B) and Baseline Visits and agree to use an effective form of birth control for the duration of the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 25
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
- •2. Subject has guttate, pustular, erythrodermic, or other non-plaque forms of psoriasis.
- •3. Subject has a physical condition which, in the investigator’s opinion, might impair evaluation of plaque psoriasis, adrenal axis function (e.g., Addison’s Disease, Cushing’s Syndrome) or which exposes the subject to an unacceptable risk by study participation.
- •4. Subject has used any phototherapy (including laser), photo-chemotherapy, or systemic psoriasis therapy including methotrexate, retinoids, cyclosporine, or biologics within 30 days prior to the initiation of treatment with the test article.
- •5. Subject has used systemic corticosteroids (including oral or intramuscular) or topical, inhaled, or intranasal corticosteroids within 30 days or 14 days, respectively, prior to Part B of the Screening Visit and/or the subject has used systemic or topical corticosteroids between Part B of the Screening Visit and the initiation of treatment.
- •6. Subject has had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to the initiation of treatment or is intending to have such exposure during the study that is thought by the investigator to likely modify the subject's disease.
- •7. Subject has used topical psoriatic therapy including tar, anthralin, retinoids, vitamin D analogs (e.g., Dovonex®) within 14 days prior to the initiation of treatment with the test article.
- •8. Subject has used emollients/moisturizers on areas to be treated within one day prior to the initiation of treatment with the test article.
- •9. Subject is currently using lithium or Plaquenil (hydroxychloroquine).
- •10. Subject is currently using a beta-blocking medication (e.g., propranolol) or angiotensin converting enzyme inhibitors (e.g., lisinopril) at a dose that has not been stabilized, in the opinion of the investigator.
- •11. Subject has a history of sensitivity to any of the ingredients in the test article (see Section 6.1).
- •12. Subject is pregnant, lactating, or is planning to become pregnant during the study.
- •13. Subject is currently enrolled in an investigational drug or device study.
- •14. Subject has used an investigational drug or investigational device treatment within 30 days prior to Visit 1 (Screening).
- •15. Subject has been previously enrolled in this study and treated with the test article.
- •16. Subject has an irregular sleep schedule or works night shifts (cortisol levels exhibit physiological diurnal variation).
- •17. Subject has a screening CST with a post 30-minute stimulation cortisol level of = 18 µg/dL.
- •18. Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.
研究者
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