UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004584 |
|---|---|
| Receipt number | R000005476 |
| Scientific Title | Bilateral comparative study of a combination of calcipotriene and nicotinamide for the treatment of psoriasis |
| Date of disclosure of the study information | 2010/12/01 |
| Last modified on | 2011/11/30 18:08:17 |
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Basic information
Public title
Bilateral comparative study of a combination of calcipotriene and nicotinamide for the treatment of psoriasis
Acronym
Combination therapy of calcipotriene and nicotinamide for psoriasis
Scientific Title
Bilateral comparative study of a combination of calcipotriene and nicotinamide for the treatment of psoriasis
Scientific Title:Acronym
Combination therapy of calcipotriene and nicotinamide for psoriasis
Region
| Japan |
Condition
Condition
psoriasis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to determine if the combination of nicotinamide with calcipotriene is more effective than calcipotriene alone for the treatment of psoriasis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We evaluate therapeutic response according to the PASI (psoriasis area and severity index).
Key secondary outcomes
We evaluate the severity of skin lesion by calculating the score of erythema, infiltration and scale of the skin lesion.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Apply 0.005%calcipotriene ointment containing 1.4% niconinamide to an indicated skin lesion twice daily everyday.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with psoriasis who visit our out-patient clinic and meet the following criteria;
1) Patients under moderate severity treated with topical therapy alone
2) Patients treated with combination therapy of ultraviolet and topical therapy
3) Patients treated with systemic therapy and topical therapy
Key exclusion criteria
Patients treated with anti TNF antibodies and patients who experienced worsening of psoriasis treated with calcipotriene will be excluded.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Wataru Fujimoto |
Organization
Kawasaki Medical School
Division name
Department of Dermatology
Zip code
Address
Matsushima 577, Kurashiki, Okayama
TEL
086-462-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Wataru Fujimoto |
Organization
Kawasaki Medical School
Division name
Department of Dermatology
Zip code
Address
Matsushima 577, Kurashiki, Okayama
TEL
086-462-1111
Homepage URL
http://www.kawasaki-m.ac.jp/med
watarufu@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
川崎医科大学附属病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.kawasaki-m.ac.jp/med
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
This clinical study ended at 11/30/2011 because the number of enrolled cases was very few.
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
| 2010 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 11 | Month | 18 | Day |
Last modified on
| 2011 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005476
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
