UMIN-CTR Clinical Trial

Public title

A study to evaluate the topical switching therapy from combined vitamin D3/corticosteroid to vitamin D3 alone in plaque psoriasis

Acronym

Topical switching therapy for plaque psoriasis

Scientific Title

A study to evaluate the topical switching therapy from combined vitamin D3/corticosteroid to vitamin D3 alone in plaque psoriasis

Scientific Title:Acronym

Topical switching therapy for plaque psoriasis

Region

Japan

Condition

Plaque Psoriasis

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study will be conducted optimal method of switching from combined vitamin D3/corticosteroid to vitamin D3 alone for plaque psoriasis.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Total PSI(Psoriasis Severity Index) score and improvement rate are evaluated at 0, 5, 10 and 14 weeks.

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Switching from topical combined vitamin D3/corticosteroid to topical vitamin D3 analogue

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

Age-lower limit

16

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1)Clinical diagnosis of plaque psoriasis amenable to topical treatment, involving arms and/or trunk and/or legs.
(2)A target lesion of scoring at least 3 for each of redness, thickness and scale, and at least 10 in total
(3)16 years of age or above

Key exclusion criteria

(1) History of allergic reaction against maxacalcitol, calcipotriol and betamethasone dipropionate
(2) Patients who have skin disease with bacterium, fungus, spirochaete, virus or skin disease with animal
(3) Patients who have ulceration, burn, cold injury
(4) Patients who have hypercalcemia
(5) Patients who have renal function deterioration
(6) Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding
(7) Topical treatment of psoriasis on the target lesion within 14 days prior to starting this study.
(8) 1) Ultraviolet therapy on target lesion within 28 days prior to starting this study.
2) Systemic treatments (e.g., vitamin D analogues, retinoids, ciclosporin ) within 28 days prior to starting this study.
(9) Systemic use of biological treatments with a potential effect on psoriasis vulgaris within the following time periods prior to starting this study:
1) secukinumab:150 days
2) ustekinumab: 120 days
3) infliximab, adalimumab:90 days
4) other products - 3 months/5 half-lives (whichever is longer).
(10) Planned initiation of, or changes in, concomitant medication that may affect psoriasis vulgaris (e.g., beta-blockers, antimalaria drugs and lithium) during the study.
(11) Those who the investigator or sub-investigator judges are ineligible

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Hajime Iizuka

Organization

Kojinkai, Association of Medical Corporation
Research Institute of Psoriasis
Hosui General Medical Clinic

Division name

Dermatology

Zip code

Address

1-4,Nishi2-chome,minami7-jo,Chuo-ku, Sapporo-shi, Hokkaido, Japan

TEL

011-520-2310

Email

iizuka_hajime_chiken@yahoo.co.jp

Name of contact person

1st name
Middle name
Last name	Katsumi Watanabe

Organization

Mebix, Inc

Division name

Research Promotion Head Office

Zip code

Address

Akasaka Intercity, 1-11-44 Akasaka, Minato-ku, Tokyo, Japan

TEL

03-6229-8936

Homepage URL

Email

k-watanabe@mebix.co.jp

Institute

Kojinkai, Association of Medical Corporation

Institute

Department

Personal name

Organization

Maruho Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

10

Month

16

Day

URL releasing protocol

Publication of results

Published

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

Recruitment status

Completed

Date of protocol fixation

2015

Year

09

Month

01

Day

Date of IRB

Anticipated trial start date

2015

Year

10

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

10

Month

16

Day

Last modified on

2017

Year

09

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022403