EUCTR2014-000291-25-IT进行中（未招募）1 期
A single-center, prospective, randomized, double-blind, intra-patient (left-to-right) placebo-controlled, pilot study to assess the efficacy and safety of a betamethasone valerate 0.1% medicated plaster in the treatment of finger nail psoriasis
IBSA Institut Biochimique S.A.0 个研究点目标入组 30 人开始时间: 2014年4月4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
- 30
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
入选标准
- •1. age =18 years;
- •2. diagnosis of nail psoriasis at both hands (nail matrix and bed with psoriatic dystrophy);
- •3. diagnosis of fingernail psoriasis alone or in association with skin and/or arthritic psoriasis, stable for at least 12 months;
- •4. Total NAPSI-Right = 12 and Total NAPSI-Left = 12;
- •5. NAPSI = 4 (nail bed and/or nail matrix disease in each of 4 nail quadrants) for the most severely involved fingernail (i.e. the target fingernail”) of each hand;
- •6. negative direct mycological examination and culture for fungus and bacteria before inclusion;
- •7. written, informed consent signed before any study procedures occur;
- •8. female subjects of childbearing potential (i.e., not status post hysterectomy or tubal ligation) with a negative urine pregnancy test at inclusion and using an appropriate method of contraception according to the definition of Note 3 of ICH M3 Guideline.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. use of any topical anti-psoriatic medications or ultraviolet treatment for fingernail psoriasis within two months before inclusion;
- •2. use of manicures or cosmetic nail products during and within seven days before inclusion;
- •3. initiation or significant change in dose/regimen of any antipsoriatic systemic treatment (i.e. retinoids, cyclosporine, methotrexate, systemic corticosteroids and biological agents) less than two months before inclusion;
- •4. infected fingernails (bacterial or fungal);
- •5. skin lesions or dermatological diseases that could interfere with the application of the plaster (e.g. dermatitis, skin ulcers, burns, skin infections, skin atrophy);
- •6. allergy to the active substance or excipients contained in the tested medication (particularly betamethasone valerate, methyl parahydroxybenzoate and propyl-parahydroxybenzoate);
- •7. underlying disease or medication that severely compromise the subject's immune system (T-lymphocytes impairment or immunosuppressive therapy);
- •8. history of anaphylaxis to drugs or allergic reactions in general which the Investigator considers to potentially affect the outcome of the study;
- •9. severe cardiac, hepatic or renal insufficiency;
- •10. pregnant or lactating women;
- •11. history of alcohol or drug abuse (within 12 months before inclusion);
- •12. clinically significant or unstable concurrent disease whose sequelae or treatment might interfere with the study evaluation parameters;
- •13. metabolic or other diseases like malignancy and major psychiatric disorders that, in the view of the Investigator, could compromise the patient’s participation in the study;
- •14. patients unable to comprehend the full nature and the purpose of the study, including possible risks and side effects, because of psycho-social or other reasons, and patients unable to cooperate with the Investigator and to comply with the requirement of the entire study (including inability to attend all the planned study visits according to the time limits);
- •15. concomitant participation in other clinical trials or participation in the evaluation of any investigational drug/device within 3 months before inclusion or previous participation in the present study;
- •16. the participation in the present study is also not permitted to employees of the Investigator or study centre with direct involvement in the trial or in other trials under the direction of that Investigator, as well as family members of the employees or the Investigator.
研究者
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