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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020325
Receipt No. 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

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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
Email 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
Email s-hasegawa@qol-rd.co.jp

Sponsor
Institute Department of Geriatric and Environmental Dermatology,
Nagoya City University Graduate School of Medical Sciences
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023119

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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