EUCTR2018-002532-24-DE进行中（未招募）1 期
A phase III, multicentre, randomised, double-blind, parallel-group trial to evaluate the efficacy and safety of a generic gel (calcipotriol + betamethasone 50 µg/g + 0.5 mg/g gel) compared to originator gel (Daivobet® gel) and vehicle in the treatment of mild to moderate plaque-type psoriasis
HELM AG0 个研究点目标入组 280 人开始时间: 2018年10月17日最近更新:
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
- 280
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. Written informed consent, personally signed and dated by the subject, is obtained prior to any trial-related activities
- •2. Male or female subjects 18 years of age or older
- •3. Clinical diagnosis of stable plaque psoriasis of at least 6 months duration (stable meaning neither spontaneously improving nor rapidly deteriorating plaque psoriasis)
- •4. Subjects with mild to moderate chronic plaque psoriasis (Psoriasis vulgaris) defined by:
- •up to 20% BSA affected with plaques (corresponding to a total area of approximately 4000 cm2)
- •PASI =5.0 to =15.0
- •category mild”, moderate” or moderate to severe” on IGA scoring
- •at the screening and baseline visits and who are suitable for topical treatment
- •5. Female volunteers of childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1 % per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra-uterine devices [IUDs], sexual abstinence in accordance to the preferred life style or vasectomized partner during the 8-week treatment period
- •*Note: Providing that partner is the sole sexual partner of the female trial participant and has received medical assessment of the surgical success.
- •6. Ability to understand and comply with study procedures and restrictions.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Pregnant or breastfeeding women
- •2. Clinically relevant history or presence of any disease or any chronic medical condition which is not well controlled (e.g., disorders of calcium metabolism, hypertension, diabetes, etc.) or surgical history which may interfere with the conduct of the trial in the opinion of the investigator
- •3. Other active skin diseases (e.g., urticaria, atopic dermatitis, etc.), skin infections (bacterial, fungal, parasitic or viral) or skin conditions that might interfere in the opinion of the investigator with treatment and evaluation of psoriasis
- •4. Acute psoriasis guttata, psoriasis punctata as well as erythrodermic, exfoliative and pustular psoriasis
- •5. Findings determined in physical examination including vital signs, or clinical laboratory safety tests which are not deemed eligible in the opinion of the investigator
- •6. Calcium test at V1 (screening) exceeding the upper limit of reference range (including serum calcium, albumin, phosphate, parathyroid hormone)
- •7. History of an allergic reaction or significant sensitivity to constituents of IMP
- •8. Contraindications according to summary of product characteristics of the originator gel (Daivobet® gel): Viral (e.g., herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers and wounds in the areas to be treated
- •9. Use of topical therapies for the treatment of psoriasis including but not limited to: corticosteroids, vitamin D analogs, retinoids, urea, salicylic acid, coal tar and anthralin during the study or having discontinued less than 2 weeks prior to randomisation
- •10. Phototherapy for the treatment of psoriasis including but not limited to: UV-A, UV-B, sunbaths less than 4 weeks, and PUVA less than 8 weeks prior to randomisation
- •11. Systemic therapies for the treatment of psoriasis including but not limited to: cyclosporine, retinoids, methotrexate, tacrolimus, azathioprine, salazosulfapyridine, apremilast and glucocorticoids less than 4 weeks prior to randomisation
- •12. Use of biologic agents for the treatment of psoriasis as follows:
- •Anti-tumor necrosis factor (TNF) drugs:
- •Adalimumab, infliximab, brodalumab, ixekizumab, etanercept: 8 weeks
- •guselkumab, certolizumab pegol, golimumab: 12 weeks
- •Other biologics:
- •Ustekinumab, alefacept, secukinumab: 24 weeks
- •Rituximab: 12 months
- •13. Treatment with systemic or locally acting medications which might have countered or influenced the trial aim (medications which are known to provoke or aggravate psoriasis, e.g. antimalarial drugs, lithium) within 8 weeks before first treatment and/or during the trial. Beta-blockers or angiotensin converting enzyme (ACE) inhibitors are allowed if on a stable dose for 3 months before study medication initiation
- •14. Use of another investigational agent or participation in the treatment phase of a clinical trial within the last 4 weeks prior to first dose or 5 half-life periods
- •15. Taking of oral vitamin D supplement, except when the subject has been on a stable dose (up to 2,000 international unit [IU] per day allowed) for at least 56 days (8 weeks) before the day of randomisation and plan to continue the dose for the duration of the trial
- •16. Taking of medicines that affect calcium metabolism (e.g. any oral prescription Vitamin D derivative
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