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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008463
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Dermatology, Tokyo Medical University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009897

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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