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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025083
Receipt No. R000028848
Scientific Title A study of long-term efficacy and safety of calcipqotriol hydrate/betamethasone dipropionate ester fixed dose combination product in patients with psoriasis vulgaris
Date of disclosure of the study information 2017/05/15
Last modified on 2017/05/15

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Basic information
Public title A study of long-term efficacy and safety of calcipqotriol hydrate/betamethasone dipropionate ester fixed dose combination product in patients with psoriasis vulgaris
Acronym A study of long-term efficacy and safety of calcipqotriol hydrate/betamethasone dipropionate ester fixed dose combination product in patients with psoriasis vulgaris
Scientific Title A study of long-term efficacy and safety of calcipqotriol hydrate/betamethasone dipropionate ester fixed dose combination product in patients with psoriasis vulgaris
Scientific Title:Acronym A study of long-term efficacy and safety of calcipqotriol hydrate/betamethasone dipropionate ester fixed dose combination product in patients with psoriasis vulgaris
Region
Japan

Condition
Condition psoriasis vulgaris
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To find evidence of efficacy and safety of long term use of Dovobet ointment on patients with psoriasis vulgaris
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes comparison of m-PASI score at week 0, week 4, week24, and week52.
Key secondary outcomes PGA and safety

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Age: 20 years old or over
2) Symptom: Manageable within 10g/day of Dovobet
3) Sex, inpatient/outpatient, does not matter
Key exclusion criteria 1) pregnant, or possibly pregnant women
2) subjects contraindicated by package insert
3) subjects judged unsuitable by physicians
4) subjects who are going to receive oral or injective steroid, cyclosporine, methotrexate, biologics, ultraviolet therapy, herbal medication against psoriasis within the trial period., 5) subjects who used Dovobet within 4 weeks before starting the trial.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichi Imafuku
Organization Fukuoka University
Division name Department of dermatology
Zip code
Address 7-45-1, Nanakuma, Jonanku, Fukuoka city
TEL 092-801-1011
Email dermatologist@mac.com

Public contact
Name of contact person
1st name
Middle name
Last name Shinichi Imafuku
Organization Fukuoka University
Division name Department of dermatology
Zip code
Address 7-45-1, Nanakuma, Jonanku, Fukuoka city
TEL 092-801-1011
Homepage URL
Email dermatologist@mac.com

Sponsor
Institute Fukuoka University
Institute
Department

Funding Source
Organization Fukuoka University
Organization
Division
Category of Funding Organization Other
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
2017 Year 05 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 No longer recruiting
Date of protocol fixation
2015 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observation of daily treated, or weekend treated, or calcipqotriol treated patients.

Management information
Registered date
2016 Year 11 Month 30 Day
Last modified on
2017 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028848

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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