Phase I, Single-center, Randomized, Controlled Trial to Evaluate the Antipsoriatic Efficacy of Calcipotriol in Novel Formulations Compared to Marketed Calcipotriol Products and Evaluation of Their Cutaneous Safety in a Psoriasis Plaque Test
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Lipidor AB
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Comparison of AKVANO-Calcipotriol formulations to their corresponding vehicles in terms of change in infiltrate thickness from baseline to Day 12
研究概览
简要总结
This was a Phase I, single-center, randomized, controlled trial to evaluate the antipsoriatic efficacy of calcipotriol in novel formulations based on AKVANO technology as compared to marketed calcipotriol products (Daivonex® solution and cream) and to evaluate their cutaneous safety in a psoriasis plaque test
详细描述
This study was conducted to evaluate the efficacy and cutaneous safety of calcipotriol (50 μg/g) in novel formulations (AKVANO®) as compared to their corresponding vehicle formulations and marketed calcipotriol formulations (Daivonex®) in a psoriasis plaque test. In total, 24 subjects with chronic psoriasis vulgaris were enrolled in this single-centre, randomized, vehicle and comparator-controlled clinical trial and were treated under occlusion over a 12-day treatment period (10 applications). The anti-psoriatic effect was evaluated by sonographic measurement of the psoriatic infiltrate and investigators' clinical efficacy assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 32 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All of the following criteria had to be met for inclusion of a subject in the clinical trial:
- •Subjects with psoriasis vulgaris in a chronic stable phase and mild or moderate plaque(s) with up to three plaque areas sufficient for six treatment fields
- •The target lesion(s) should have been on the trunk or extremities (excluding palms/soles); psoriatic lesion on the knees were not used as a target lesion
- •Plaques to be treated should have had a comparable psoriatic infiltrate thickness of at least 200 μm
- •The physical examination of the skin had to be without disease findings unless the investigator considered an abnormality to be irrelevant to the outcome of the clinical trial
- •Female volunteers of childbearing potential had to be either 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 or had a vasectomized partner
- •Written informed consent obtained
排除标准
- •Subjects were excluded from the clinical trial when one or more of the following conditions were met:
- •Other skin disease noted on physical examination that was considered by the investigator to be relevant to the outcome of the trial;
- •Subjects with psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, psoriasis arthropathica and pustular psoriasis
- •Any topical antipsoriatic treatment on the plaques to be treated in this trial (including corticosteroids, except for salicylic acid) in the three months before first treatment and/or during the trial
- •Systemic treatment with antipsoriatics e.g. corticosteroids, cytostatics, retinoids in the three months before first treatment and during the trial
- •Treatment with systemic or locally acting medications which might have countered or influenced the trial aim (medications which were known to provoke or aggravate psoriasis, e.g. ß-blocker, antimalarial drugs, lithium) within three months before first treatment and/or during the trial
- •Known allergic reactions irritations or sensitivity to the active ingredients or other components of the investigational products;
- •Contraindications according to summary of product characteristics of Daivonex®
- •Evidence of drug or alcohol abuse
- •Pregnancy or nursing
- •UV-therapy within four weeks before first treatment and during the trial
- •Symptoms of a clinically significant illness that might have influenced the outcome of the trial in the four weeks before first treatment and during the trial
- •Participation in the treatment phase of another clinical trial within the last four weeks prior to the first treatment in this clinical trial
- •In the opinion of the investigator or physician performing the initial examination the subject should not have participated in the clinical trial, e.g. due to probable non-compliance 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 subject was an employee of sponsor
- •Subject was institutionalized because of legal or regulatory order
研究组 & 干预措施
Single arm with several test fields
Altogether six test fields (two active formulations, their corresponding vehicles and two comparators) located on the torso, or the extremities were randomly assigned for treatments per subject.
干预措施: AKVANO-Calcipotriol formulation 1 (Drug)
Single arm with several test fields
Altogether six test fields (two active formulations, their corresponding vehicles and two comparators) located on the torso, or the extremities were randomly assigned for treatments per subject.
干预措施: AKVANO-Calcipotriol formulation 2 (Drug)
Single arm with several test fields
Altogether six test fields (two active formulations, their corresponding vehicles and two comparators) located on the torso, or the extremities were randomly assigned for treatments per subject.
干预措施: AKVANO vehicle formulation 1 (Drug)
Single arm with several test fields
Altogether six test fields (two active formulations, their corresponding vehicles and two comparators) located on the torso, or the extremities were randomly assigned for treatments per subject.
干预措施: AKVANO vehicle formulation 2 (Drug)
Single arm with several test fields
Altogether six test fields (two active formulations, their corresponding vehicles and two comparators) located on the torso, or the extremities were randomly assigned for treatments per subject.
干预措施: Daivonex solution (Drug)
Single arm with several test fields
Altogether six test fields (two active formulations, their corresponding vehicles and two comparators) located on the torso, or the extremities were randomly assigned for treatments per subject.
干预措施: Daivonex cream (Drug)
结局指标
主要结局
Comparison of AKVANO-Calcipotriol formulations to their corresponding vehicles in terms of change in infiltrate thickness from baseline to Day 12
时间窗: 12 days
The thickness of psoriatic infiltrate will be recorded as echo lucent psoriatic band (ELB) using a 20 MHz high frequency sonograph (PROFI USB, Taberna pro Medicum, Lueneburg) on day 1 (baseline) and day 12 (end of treatment; EoT). Mean change of infiltrate thickness will be determined.
次要结局
- Comparison of AKVANO-Calcipotriol formulations to their corresponding comparators (Daivonex solution and cream) in terms of change in infiltrate thickness from baseline to Day 12(12 days)
- Comparison of AKVANO-Calcipotriol formulations to their corresponding vehicles and comparators in terms of change in infiltrate thickness and Area under curve (AUC) of change in infiltrate thickness from baseline to Day 8(8 days)
- Clinical assessment of the treatment efficacy of all formulations at day 12(12 days)
- Clinical assessment of the treatment efficacy of all formulations at day 8(8 days)