An International, Multi-centre, Prospective, Non-controlled, Open, Single-group, 8-week Trial in Adolescent Subjects
Effect of Calcipotriol Plus Betamethasone Dipropionate Gel on the HPA Axis and Calcium Metabolism in Adolescent Subjects (Aged 12 to 16 Years, 11 Months) With Scalp and Body Psoriasis
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Manitoba
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Winnipeg、Manitoba、加拿大、R3C 0N2
- Winnipeg Clinic
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Newfoundland and Labrador
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St-John's、Newfoundland and Labrador、加拿大、A1A 4Y3
- Adult, Pediatric and Laser Derma
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Ontario
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Markham、Ontario、加拿大、L3P 1A8
- Lynderm Research Inc.
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Peterborough、Ontario、加拿大、K9J 1Z2
- SKiN Centre for Dermatology
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Berlin、德国、10117
- Charite Berlin
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Bonn、德国、53127
- Uniklinik Bonn
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Frankfurt am Main、德国、60590
- Uniklinik Frankfurt
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Hamburg、德国、22149
- Katholisches Kinderkrankenhaus
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Alpe-Maritimes
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Nice、Alpe-Maritimes、法国、06202
- CHU de Nice
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Bouches-du-Rhône
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Martigues、Bouches-du-Rhône、法国、13500
- Cabinet Medical
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Finistère
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Quimper、Finistère、法国、29107
- CHI de Cornouaille
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Karczew、波兰、05-480
- Endo - Med. Centrum Medyczne Clinic
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Lublin、波兰、20-146
- NZOZ Med.-Laser Clinic
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Ostróda、波兰、14-100
- Specjalistyczny Ofrodek Leczniczo Clinic
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Warszawa、波兰、00-660
- Medycyna Kliniczna Clinic
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Wrocław、波兰、51-318
- Derm Medica Sp.zo.o. Clinic
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Brasov、罗马尼亚、500152
- Policlinica de Diagnostic Rapid S.A. Clinic
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Bucharest、罗马尼亚、20125
- Spitalul Clinic "Colentina"
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Cluj-Napoca、罗马尼亚、400006
- Spitalul Clinic Judetean de Urgenta Cluj-Napoca
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Galati、罗马尼亚、800101
- Cabinet Medical Individual Tatu G. Alin Laurentiu
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Iasi、罗马尼亚、700381
- Iasiprest SRL Dermato-Venerology
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Targu-Mures、罗马尼亚、800373
- Spitalul Clinic Judetean Mures
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Timisoara、罗马尼亚、300077
- Spitalul Clinic Municipal de Urgenta Timisoara
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California
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San Diego、California、美国、92132
- Rady's Children Hospital
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Florida
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Tampa、Florida、美国、33612
- Clinical Research Center, Morsani Center for Advanced Healthcare
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Indiana
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Indianapolis、Indiana、美国、46202
- Indiana University
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Nebraska
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Omaha、Nebraska、美国、68144
- Skin Specialists, PC
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New York
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Forest Hills、New York、美国、10025
- St. Luke's Roosevelt Hospital
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Rhode Island
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Johnston、Rhode Island、美国、12095
- Clinical Partners
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South Carolina
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Charleston、South Carolina、美国、29407
- Dermatology and Laser Center of Charleston, PA
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Texas
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San Antonio、Texas、美国、78229
- Clinical Trials of Texas, Inc.
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Greater Manchester
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Manchester、Greater Manchester、英国、M13 9WL
- Manchester Royal Infirmary
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Lanarkshire
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Airdrie、Lanarkshire、英国、ML6 OJ5
- Monklands Hospital
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London
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Leytonstone、London、英国、E11 1NR
- Whipps Cross University Hospital
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Monmouthshire
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Stow Hill, Newport、Monmouthshire、英国、NP20 4SZ
- St. Woolos Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria (all subjects):
- Clinical signs of psoriasis vulgaris on both the scalp and body (trunk and/or limbs)
At SV2 and Visit 1, a clinical diagnosis of scalp and body (trunk and/or limbs) psoriasis which is:
- of an extent of 10 to 35% of the body surface area (excluding psoriatic lesions of the face and sensitive areas. Sensitive areas include armpits, groin, under the breasts and in other skin folds around the genitals and buttocks), and
- of at least moderate severity according to the investigator's global assessment of disease severity on the body.
- A serum albumin-corrected calcium level below the upper reference limit at SV2
Inclusion Criteria (for subjects performing HPA axis assessments):
At SV2 and Visit 1, a clinical diagnosis of scalp psoriasis which is:
- more than or equal to 20% of the scalp area, and
- of at least moderate severity according to the investigator's global assessment of disease severity on the scalp.
- Subjects with a normal HPA axis function at SV2 including serum cortisol concentration above 5 mcg/dl before ACTH challenge and serum cortisol concentration above 18 mcg/dl 30 minutes after ACTH challenge.
Inclusion Criteria (for subjects not performing HPA axis assessments):
At SV2 and Visit 1, a clinical diagnosis of scalp psoriasis which is:
- more than or equal to 10% of the scalp area, and
- of at least moderate severity according to the investigator's global assessment of disease severity on the scalp.
Exclusion Criteria (all subjects):
Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on scalp and/or body psoriasis within the following time period prior to Visit 1 and during the trial:
- etanercept - within 4 weeks prior to Visit 1
- adalimumab, infliximab - within 2 months prior to Visit 1
- ustekinumab - within 4 months prior to Visit 1
- experimental products - within 4 weeks/5 half-lives (whichever is longer) prior to Visit 1
- Systemic treatment with therapies other than biologicals, with a possible effect on scalp and/or body psoriasis (e.g., retinoids, immunosuppressants, PUVA) within 4 weeks prior to Visit 1 (Day 0) or during the trial.
- UVB therapy within 2 weeks prior to Visit 1 or during the trial.
- Any topical treatment on the scalp and body (except for emollients and non-steroid medicated shampoos) within 2 weeks prior to Visit 1 or during the trial.
- Systemic calcium, vitamin D supplements, antacids, diuretics, antiepileptics, diphosphonates or calcitonin within 4 weeks prior to SV2 or during the trial.
- Planned initiation of, or changes to, concomitant medication that could affect psoriasis (e.g., betablockers, chloroquine, lithium, ACE inhibitors) during the trial.
- Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
- Subjects with any of the following conditions present on the treatment areas on scalp and/or body: viral (e.g., herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, acne vulgaris, acne rosacea, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, ulcers and wounds.
- Other inflammatory skin diseases that may confound the evaluation of scalp and/or body psoriasis.
- Planned excessive exposure to sun during the trial that may affect scalp and/or body psoriasis.
- Known or suspected severe renal insufficiency or severe hepatic disorders.
- Known or suspected disorders of calcium metabolism associated with hypercalcaemia.
- Any clinically significant abnormality following review of screening laboratory tests (blood and urine samples), physical examination or blood pressure/heart rate measurement performed at SV2.
- Current participation in any other interventional clinical trial.
- Previously enrolled in this trial.
- Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within a month prior to SV1 or longer, if the class of substance required a longer wash-out as defined above (e.g., biological treatments).
- Subjects or parent(s) or legal guardian known or suspected of being unlikely to comply with the Clinical Trial Protocol (e.g., alcoholism, drug dependency or psychotic state).
- Females who are pregnant, or of child-bearing potential and wishing to become pregnant during the trial, or who are breast-feeding.
- Females of child-bearing potential with positive pregnancy test at SV2.
- Subject (or their partner) not using an adequate method of contraception according to national requirements.
Exclusion Criteria (for subjects performing HPA axis assessments)
- A history of serious allergy, allergic asthma or serious allergic skin rash.
- Known or suspected hypersensitivity to any component of CORTROSYN® (including ACTH/cosyntropin/tetracosactide)
- Systemic treatment with corticosteroids (including inhaled and nasal steroids) within 12 weeks prior to SV2 or during the trial.
- Topical treatment with corticosteroids within 2 weeks prior to SV2 or during the trial.
- Oestrogen therapy (including contraceptives) or any other medication known to affect cortisol levels levels or HPA axis integrity within 4 weeks prior to SV2 or during the trial.
- Enzymatic inductors (e.g., barbiturates, phenytoin, rifampicin) within 4 weeks prior to SV2 or during the trial.
- Systemic or topical cytochrome P450 inhibitors (e.g., ketoconazole, itraconazole, metronidazole) within 4 weeks prior to SV2 or during the trial. Topical ketoconazole 2 weeks prior to SV2.
- Hypoglycemic sulfonamides within 4 weeks prior to SV2 or during the trial.
- Antidepressive medications within 4 weeks prior to SV2 or during the trial.
- Known or suspected endocrine disorder that may affect the results of the ACTH challenge test.
- Clinical signs or symptoms of Cushing's disease or Addison's disease.
- Subjects with diabetes mellitus.
- Known or suspected cardiac condition.
- Not following nocturnal sleep patterns.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:LEO 80185凝胶
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Adverse Drug Reactions (ADRs)
大体时间:8 weeks
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Number of Adverse Drug Reactions (ADRs)
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8 weeks
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Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4
大体时间:30 minutes after ACTH-challenge at Week 4
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Number of subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 4
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30 minutes after ACTH-challenge at Week 4
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Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 8
大体时间:30 minutes after ACTH-challenge at Week 8
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Number of subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 8
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30 minutes after ACTH-challenge at Week 8
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Change in Albumin-corrected Serum Calcium From Baseline to Week 4
大体时间:From baseline to Week 4
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Change in albumin-corrected serum calcium from baseline to Week 4
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From baseline to Week 4
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Change in Albumin-corrected Serum Calcium From Baseline to Week 8
大体时间:From baseline to Week 8
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Change in albumin-corrected serum calcium from baseline to Week 8
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From baseline to Week 8
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Change in Albumin-corrected Serum Calcium From Baseline to End of Treatment
大体时间:From baseline to end of treatment
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Change in albumin-corrected serum calcium from baseline to end of treatment, defined as the last value recorded after baseline up to and including Week 8.
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From baseline to end of treatment
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Change in 24-hour Urinary Calcium Excretion From Baseline to Week 4
大体时间:From baseline to Week 4
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Change in 24-hour urinary calcium excretion from baseline to Week 4
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From baseline to Week 4
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Change in 24-hour Urinary Calcium Excretion From Baseline to Week 8
大体时间:From baseline to Week 8
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Change in 24-hour urinary calcium excretion from baseline to Week 8
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From baseline to Week 8
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Change in 24-hour Urinary Calcium Excretion From Baseline to End of Treatment
大体时间:From baseline to end of treatment
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Change in 24-hour urinary calcium excretion from baseline to end of treatment, defined as the last value recorded after baseline up to and including Week 8.
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From baseline to end of treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Adverse Events (AEs)
大体时间:8 weeks
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Number of Adverse Events (AEs)
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8 weeks
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Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at Both 30 and 60 Minutes After ACTH-challenge at Week 4
大体时间:30 and 60 minutes after ACTH-challenge at Week 4
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Number of subjects with serum cortisol concentration of ≤18 mcg/dl at both 30 and 60 minutes after ACTH-challenge at Week 4
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30 and 60 minutes after ACTH-challenge at Week 4
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Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at Both 30 and 60 Minutes After ACTH-challenge at Week 8
大体时间:30 and 60 minutes after ACTH-challenge at Week 8
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Number of subjects with serum cortisol concentration of ≤18 mcg/dl at both 30 and 60 minutes after ACTH-challenge at Week 8
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30 and 60 minutes after ACTH-challenge at Week 8
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Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 4
大体时间:From baseline to Week 4
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Change in urinary calcium:creatinine ratio from baseline to Week 4
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From baseline to Week 4
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Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 8
大体时间:From baseline to Week 8
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Change in urinary calcium:creatinine ratio from baseline to Week 8
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From baseline to Week 8
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Change in Serum Alkaline Phosphatase From Baseline to Week 4
大体时间:From baseline to Week 4
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Change in serum alkaline phosphatase from baseline to Week 4
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From baseline to Week 4
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Change in Serum Alkaline Phosphatase From Baseline to Week 8
大体时间:From baseline to Week 8
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Change in serum alkaline phosphatase from baseline to Week 8
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From baseline to Week 8
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Pharmacokinetic Evaluation AUC(0-t)
大体时间:Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP
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AUC(0-t) values for betamethasone dipropionate, betamethasone 17-propionate, calcipotriol, and MC1080.
Betamethasone dipropionate was only detected above lower limit of quantification in 5 samples from 4 subjects, and no subjects had enough positive samples to allow calculation AUC(0-t) for betamethasone dipropionate.
Betamethasone 17-propionate was only detected in 12 samples from 5 subjects, and only 2 subjects had enough positive samples to calculate AUC(0-t).
The mean value of AUC(0-t) for these 2 subjects is presented for betamethasone 17-propionate.
Calcipotriol and MC1080 were never detected above lower limit of quantification, therefore no PK parameters could be calculated and no data have been entered for calcipotriol and MC1080.
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Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP
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Pharmacokinetic Evaluation AUC(0-infinity)
大体时间:Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP
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AUC(0-infinity) values for betamethasone dipropionate, betamethasone 17-propionate, calcipotriol, and MC1080. Betamethasone dipropionate was only detected above lower limit of quantification in 5 samples from 4 subjects, and no subjects had enough positive samples to allow calculation AUC(0-infinity) for betamethasone dipropionate. Betamethasone 17-propionate was only detected in 12 samples from 5 subjects, and only 2 subjects had enough positive samples to calculate AUC(0-infinity). The mean value of AUC(0-infinity) for these 2 subjects is presented for betamethasone 17-propionate. Calcipotriol and MC1080 were never detected above lower limit of quantification, therefore no PK parameters could be calculated and no data have been entered for calcipotriol and MC1080. The terms AUC(0-infinity) and AUC(all) are interchangeable, AUC(0-infinity) was used in the protocol whereas AUC(all) was used in the report. AUC(0-infinity) has been used here to be consistent with the protocol. |
Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP
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Pharmacokinetic Evaluation C(Max)
大体时间:Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP
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C(max) values for betamethasone dipropionate, betamethasone 17-propionate, calcipotriol, and MC1080.
Betamethasone dipropionate was only detected above lower limit of quantification in 5 samples from 4 subjects and betamethasone 17-propionate was only detected in 12 samples from 5 subjects, therefore pharmacokinetic profiles could not be calculated.
Presented C(max) values for betamethasone dipropionate and betamethasone 17-propionate are the the single highest concentrations measured in any sample at any time.
Calcipotriol and MC1080 were never detected above lower limit of quantification, therefore no PK parameters could be calculated and no data have been entered for calcipotriol and MC1080.
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Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP
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Pharmacokinetic Evaluation T(Max)
大体时间:Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP
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T(max) values for betamethasone dipropionate, betamethasone 17-propionate, calcipotriol, and MC1080.
Betamethasone dipropionate was only detected above lower limit of quantification in 5 samples from 4 subjects and betamethasone 17-propionate was only detected in 12 samples from 5 subjects.
Therefore it was not possible to calculate T(max) for betamethasone dipropionate and betamethasone 17-propionate.
Calcipotriol and MC1080 were never detected above lower limit of quantification, therefore no PK parameters could be calculated and no data have been entered for calcipotriol and MC1080.
|
Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP
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Pharmacokinetic Evaluation T(½)
大体时间:Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP
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T(½) values for betamethasone dipropionate, betamethasone 17-propionate, calcipotriol, and MC1080.
Betamethasone dipropionate was only detected above lower limit of quantification in 5 samples from 4 subjects and betamethasone 17-propionate was only detected in 12 samples from 5 subjects, therefore it was not possible to calculate T(½) for betamethasone dipropionate or betamethasone 17-propionate.
Calcipotriol and MC1080 were never detected above lower limit of quantification, therefore no PK parameters could be calculated and no data have been entered for calcipotriol and MC1080.
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Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP
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Subjects With "Controlled Disease" According to the Investigator's Global Assessment of Disease Severity on the Body at End of Treatment
大体时间:End of treatment
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Subjects with "Controlled disease" (i.e., "Clear" or "Almost clear" for subjects with at least "Moderate" disease at baseline, "Clear" for subjects with "Mild" disease at baseline) according to the investigator's global assessment of disease severity on the body at end of treatment, defined as the last value recorded up to and including Week 8.
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End of treatment
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Percentage Change in PASI From Baseline to End of Treatment
大体时间:From baseline to end of treatment
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Percentage change in Psoriasis area and severity index (PASI) score from baseline to end of treatment, defined as the last value recorded up to and including Week 8. Psoriasis area and severity index (PASI) assesses extent and severity of clinical signs of psoriasis vulgaris.
Body surface is divided in 4 ares: head (incl.
neck), arms (incl.
hands), trunk (incl.
flexures) and legs (incl.
buttocks and feet).
Each area is scored from 0-6 for extent of psoriasis and from 0-4 for redness, thickness, and scaliness, and an area PASI score is calculated.
The total PASI score is calculated from each area's score.
The PASI score ranges from 0 (clear skin) to 72 (maximum disease), a PASI score higher than 10 generally corresponds to moderate-to-severe disease.
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From baseline to end of treatment
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Subjects With "Controlled Disease" According to the Patient's Global Assessment of Disease Severity on the Body at End of Treatment
大体时间:End of treatment
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Subjects with "Controlled disease" (i.e., "Clear" or "Almost clear" for subjects with at least "Moderate" disease at baseline, "Clear" for subjects with "Mild" disease at baseline) according to the patient's global assessment of disease severity on the body at end of treatment, defined as the last value recorded up to and including Week 8.
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End of treatment
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合作者和调查者
赞助
调查人员
- 首席研究员:Lawrence Eichenfield, MD、Rady Chilidren's Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.