UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020325 |
|---|---|
| Receipt number | R000023119 |
| Scientific Title | A study to determine the incidence of hypercalcemia with calcipotriol hydrate/betamethasone dipropionate ester fixed dose combination product in patients with severe psoriasis vulgaris |
| Date of disclosure of the study information | 2015/12/24 |
| Last modified on | 2017/07/03 09:12:34 |
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Basic information
Public title
A study to determine the incidence of hypercalcemia with calcipotriol hydrate/betamethasone dipropionate ester fixed dose combination product in patients with severe psoriasis vulgaris
Acronym
A study on the incidence of hypercalcemia with calcipotriol hydrate/betamethasone dipropionate ester fixed dose combination product in severe psoriasis vulgaris patients
Scientific Title
A study to determine the incidence of hypercalcemia with calcipotriol hydrate/betamethasone dipropionate ester fixed dose combination product in patients with severe psoriasis vulgaris
Scientific Title:Acronym
A study on the incidence of hypercalcemia with calcipotriol hydrate/betamethasone dipropionate ester fixed dose combination product in severe psoriasis vulgaris patients
Region
| Japan |
Condition
Condition
Severe psoriasis vulgaris
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To obtain evidence with regard to the incidence of hypercalcemia with calcipotriol hydrate/betamethasone dipropionate ester fixed dose combination product in severe psoriasis vulgaris patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum calcium level changes
Key secondary outcomes
Safety evaluation
-Adverse events (subjective symptoms, objective symptoms, abnormal changes in physical examination data, and laboratory test data)
-Laboratory test data and physical examination data changes over time
Efficacy evaluation
-m-PASI over time
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Appropriate amount of study drug should be applied once daily to whole area affected by skin rash of psoriasis vulgaris.
(for patients with skin rash over >=20% of body surface area [BSA], the appropriate amount of Dovobet ointment to be applied is >=5 g per day, not exceeding 90 g per week)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with plaque-type psoriasis vulgaris who have skin rash on the starting day of the study treatment, with 20%<=BSA<=30%.
2) Patients with age >=18 years at the time of obtaining written consent.
However, if the patient is younger than 20 years of age, obtaining written consent from a delegate is required.
3) Gender - Not applicable
4) Inpatient/outpatient - Not applicable
Key exclusion criteria
1. Serious allergy
2. Hypersensitivity to any ingredients in the study drug
3. Patients with skin infection due to bacteria, fungi, spirochetes, or viruses, or with an animal skin infection
4. Patients with ulcer, and frostbite/heat burn
5. Severe hepatic / renal / cardiac / pulmonary or other disorder which requires hospitalization
6. Skin disease concurrent with skin rash of psoriasis vulgaris
7. Patients who have been administered biologics, or retinoids within 3 months from the starting day of the study treatment
8. Patients who have received the following treatment within 4 weeks from the starting day of the study treatment
1) Phototherapy for skin rash of psoriasis vulgaris
2) The following systemic drugs:
a) Vitamin D derivatives
b) Drugs which may affect calcium metabolism
c) Drugs which may affect the immune system
d) Tar products
e) Other drugs which have an indication of psoriasis
9. Patients who have taken the following therapeutic drugs or food within 2 weeks from the starting day of the study treatment
1) Topical vitamin D derivatives or supplements which contain vitamin D
2) The following topical drugs for skin rash of psoriasis vulgaris:
10. Patients whose laboratory test data collected before the starting day of the study treatment meets any of the criteria listed below
a) Serum calcium and serum creatinine level >upper limit of the normal range
b) AST and ALT level >=3 multiplied by upper limit of the normal range
11. Pregnant women, breastfeeding women, women who plan to get pregnant during the study period
12. Other patients whom the investigator or the subinvestigator have judged to be non-eligible as a subject
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akimichi Morita |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Geriatric and Environmental Dermatology
Zip code
Address
1-Kawasumi, Mizuho-cho, Mizuho-ku Nagoya-shi, Aichi, 467-8601, Japan
TEL
052-853-8261
amorita@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sayumi Hasegawa |
Organization
QOL RD Co.,Ltd.
Division name
CRO Department Drug Division
Zip code
Address
Fron Place Nihonbashi Bldg. 2-14-1, Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan
TEL
03-6386-8800
Homepage URL
s-hasegawa@qol-rd.co.jp
Sponsor or person
Institute
Department of Geriatric and Environmental Dermatology,
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
LEO Pharma K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 26 | Day |
Date of closure to data entry
| 2016 | Year | 11 | Month | 17 | Day |
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 11 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 24 | Day |
Last modified on
| 2017 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023119
| Research Plan | |
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| Registered date | File name |
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