EUCTR2019-000215-92-FR进行中（未招募）1 期
Prospective, randomized, double blinded, placebo controlled, multicentre study for the evaluation of efficacy and safety of a Tacrolimus-containing solution (TACRO-Skin) in subjects with mild to severe scalp psoriasis as well as recording of the systemic bioavailability of Tacrolimus - ScaTAC
Bay Pharma GmbH0 个研究点目标入组 128 人开始时间: 2019年3月5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
- 128
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) Subjects must be able to understand the scope, risks and nature of the clinical study and decide
- •independently on their participation
- •2) Males and females aged 18 years or older at the time of informed consent
- •3) Caucasian
- •4) Women of childbearing age must use an established contraceptive method (e.g. contraceptive pill,
- •depot injection, spiral, abstinence, vasectomy of the partner), exceptions: 12 months of natural
- •amenorrhoea, postoperatively (6 weeks after bilateral ovariectomy with or without hysterectomy)
- •5) Women of childbearing age must demonstrate a negative pregnancy test (urine rapid test)
- •6) Mild to moderate psoriasis vulgaris (plaque psoriasis) with scalp involvement for at least 6 months
- •7) s-IGA of 2 (mild scalp involvement) to 4 (severe scalp involvement) and 20% or higher or 5x5 cm
- •or larger of scalp surface area (or 0.5% of Body Surface Area) affected
- •8) Discontinuation of systemic therapy with etanercept at least 4 weeks before start of study
- •treatment (Visit 2 - baseline)
- •9) Discontinuation of systemic therapy with adalimumab and infliximab at least 12 weeks before start
- •of study treatment (Visit 2 - baseline)
- •10) Discontinuation of systemic therapy with ustekinumab, all other biologics (incl. but not limited to
- •IL 17 antagonists and IL-23 antagonists), and tacrolimus at least 12 weeks before start of study
- •treatment (Visit 2 - baseline)
- •11) At least 4 weeks before start of study treatment (Visit 2 - baseline) discontinuation with other
- •systemic therapies that have an effect on psoriasis, such as corticosteroids, methotrexate,
- •retinoids, ciclosporin, fumaric acid esters, sulfasalzine, hydroxycarbamide, azathioprine,
- •apremilast and other immunosuppressant or immunomodulating drugs
- •12) Discontinuation of UV therapy at least 4 weeks before start of study treatment (Visit 2 - baseline)
- •13) Discontinuation of topical treatment such as steroids, Vitamin D, tar, salicylic acid, dimeticon, and
- •urea of scalp psoriasis at least 2 weeks before start of study treatment (Visit 2 - baseline)
- •14) Discontinuation of other physical and alternative therapy procedures (e.g. brine bath) at least
- •4 weeks before the start of study treatment (Visit 2 - baseline)
- •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 101
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 27
排除标准
- •Subjects meeting any of the following criteria will not be permitted to enter the study:
- •1) Participation in another clinical study at least 4 weeks before the inclusion date
- •2) Pregnancy, planned pregnancy, lactation period
- •3) Chronic inflammatory skin or systemic disease or a skin or systemic disease affecting the barrier
- •function of the skin, with the exception of psoriasis
- •4) Taking psoriasigen medicines (beta-blocker, angiotensin-converting-enzyme (ACE) inhibitors,
- •lithium, antimalarials). If beta-blockers and ACE inhibitors are taken for a longer period of time (at a stable dose at least 2 weeks before start of study treatment (Visit 2 - baseline)), the inclusion is
- •at the discretion of the Investigator
- •5) Intensive sun exposure (holiday, solarium) at least 4 weeks before start of study treatment (Visit 2
- •- baseline) and during the study
- •6) Non-drug treatments that could interfere with the conduct of the study
- •7) Use of vasoactive over-the-counter (OTC) products that interfere with the inflammation process of
- •the skin in the scalp area
- •8) Use of nutritional supplements that can affect inflammatory processes in the body
- •9) Use of calcineurin inhibitors during the study
- •10) Topical application of cosmetic or hair care products during the study (hair gel, hair spray, etc.)
- •11) Use of medical shampoos (e.g. tar shampoo)
- •12) Current or potential contraindications, incompatibility or hypersensitivity to any of the ingredients of
- •13) Known drug abuse
- •14) Risk of haematological contagion (Human Immunodeficiency Virus (HIV), chronic or active
- •Hepatitis B or C)
- •15) Subjects in close affiliation with the study personnel (e.g. immediate family member or
- •subordinate), subjects who are a member of the clinical study personnel, or an employee of the
- •sponsor or a CRO involved in the study
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