EUCTR2013-004519-28-DE进行中（未招募）不适用
A phase II trial to evaluate the anti-psoriatic efficacy and tolerability of tazarotene in a gel formulation in patients with mild to moderate nail psoriasis - parallel group comparison
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •men and women aged 18 to 75;
- •mild to moderate nail psoriasis on one target fingernail (mNAPSI 12 to 50 inclusive at screening and Day 1);
- •nail growth of the target fingernail of =1 mm per month;
- •the physical examination of the skin including nails must be without further disease findings (other than psoriasis) unless the investigator considers an abnormality to be irrelevant to the outcome of the study;
- •subjects with body psoriasis must have chronic, stable, mild to moderate body psoriasis;
- •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 intrauterine devices (IUDs), sexual abstinence or had a vasectomized partner
- •written informed consent obtained.
- •* Females NOT of childbearing potential are defined as those who have been surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or who are postmenopausal (defined as continuous amenorrhea of at least 2 years
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •pustular psoriasis;
- •target fingernail thicker than 2 mm at free edge (if necessary, a sliding caliper for measurement of thickness will be used);
- •concomitant onychomycosis of the target fingernail shown by negative culture;
- •any other skin condition, with a potential to affect the nails or to interfere with evaluation of the disease;
- •history of hypersensitivity to tazarotene or to drugs with similar chemical structures or to other components of the study medication or to the adhesive bandage;
- •topical treatment of nails with antipsoriatics (e.g. topical nail application of corticosteroids, retinoids, vitamin D analogues, 5-fluorouracil or anthralin) in the 4 weeks preceding the treatment phase and during the trial including the 3-month follow-up period;
- •systemic treatment of psoriasis within the three months before the treatment phase of the trial or during the trial including the 3-month follow-up period with antipsoriatics e.g. retinoids, cytostatics, corticosteroids, immunosuppressive therapy, or biologics, with the exception of ustekinumab, which should not have been taken within the six months prior to the treatment phase or during the trial.);
- •intralesional steroid injection in the nail fold within the three months before the treatment phase of the trial or during the trial;
- •phototherapy (including UVB and PUVA) within three months before the treatment phase of the trial;
- •treatment with systemic or locally acting medications which might counter or influence the trial aim or medications e.g. those which are known to provoke or aggravate psoriasis, such as antimalarial drugs, lithium, beta-blockers and indomethacin within 4 weeks before the treatment phase of the trial and during the trial;
- •any chronic infection or condition capable of interfering with the conduct of the trial;
- •evidence of drug or alcohol abuse;
- •symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks preceding the treatment phase of the trial;
- •participation in the treatment phase of another clinical trial within the last 4 weeks prior to first treatment in this clinical trial;
- •pregnancy or nursing;
- •in the opinion of the investigator or physician performing the initial examination the patient should not participate in the trial, e.g. due to probable noncompliance or inability to understand the trial and give adequately informed consent;
- •close affiliation with the investigator (e.g. a close relative) or persons working at bioskin GmbH, or the patient is an employee of the sponsor;
- •patient is institutionalized because of a legal or regulatory order.
研究者
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