UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to determine the incidence of hypercalcemia with calcipotriol hydrate/betamethasone dipropionate ester fixed dose combination product in patients with severe psoriasis vulgaris
Title of the study (Brief title)	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	Akimichi Morita
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Geriatric and Environmental Dermatology
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	Sayumi Hasegawa
Organization	QOL RD Co.,Ltd.
Division name	CRO Department Drug Division
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000023119