UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008463 |
|---|---|
| Receipt number | R000009897 |
| Scientific Title | A clinical trial to evaluate the effect of levocetirizine on pruritic skin diseases. |
| Date of disclosure of the study information | 2012/07/20 |
| Last modified on | 2013/03/28 10:19:40 |
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Basic information
Public title
A clinical trial to evaluate the effect of levocetirizine on pruritic skin diseases.
Acronym
A clinical trial to evaluate the effect of levocetirizine on pruritic skin diseases.
Scientific Title
A clinical trial to evaluate the effect of levocetirizine on pruritic skin diseases.
Scientific Title:Acronym
A clinical trial to evaluate the effect of levocetirizine on pruritic skin diseases.
Region
| Japan |
Condition
Condition
Pruritic skin diseases
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
First we aim to evaluate the effect of standard dose of levocetirizine on pruritic skin diseases. When it doesn't work well, then we will compare the effect of up-dosing to changing other antihistamine. And we will also assess the non-sedative antihistamine's effect on the daytime drowsiness and nocturnal sleep.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Itch: Visual analog scale
Key secondary outcomes
Itch: Scratch score
Severity: Objective SCORAD
QOL: DLQI, Skindex16
Daytime drowsiness: ESS
Nocturnal sleep: Pittsburgh Sleep Quality Index (PSQI)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Six weeks-treatment with levocetirizine(5mg once daily)
Interventions/Control_2
After 2 weeks-treatment with levocetirizine(5mg once daily), 4 weeks-treatment with levocetirizine(10mg once daily)
Interventions/Control_3
After 2 weeks-treatment with levocetirizine(5mg once daily), 4 weeks-treatment with fexofenadine(60mg twice daily)
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients aged 16 years or older at the time of registration.
2)Patients who received an explanation of the study detail and signed a written consent form.
Key exclusion criteria
1)Patients with an acute infection.
2)Patients treated with ultraviolet therapy or subcutaneous allergen-specific immunotherapy.
3)Patients treated with corticosteroid orally or injections.
4)Patients who drive a car or engaging in hazardous occupations.
5)Patients who are pregnant or possibly pregnant women, or breastfeeding women.
6)Patients who has sever complicating diseases like hepatic disease, kidney disease, hart disease.
7)Patients who are judged inappropriate to participate in the study by the investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryoji Tsuboi |
Organization
Tokyo Medical University
Division name
Department of Dermatology
Zip code
Address
6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo 160-0023 Japan
TEL
03-3342-6111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokyo Medical University
Division name
Department of Dermatology
Zip code
Address
TEL
03-3342-6111
Homepage URL
Sponsor or person
Institute
Department of Dermatology, Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 06 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 18 | Day |
Last modified on
| 2013 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009897
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
