UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017536 |
|---|---|
| Receipt number | R000019782 |
| Scientific Title | A study to evaluate the efficacy of proactive therapy with topical agents and antihistamines during the maintenance phase of atopic dermatitis. |
| Date of disclosure of the study information | 2015/05/14 |
| Last modified on | 2017/06/07 18:15:45 |
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Basic information
Public title
A study to evaluate the efficacy of proactive therapy with topical agents and antihistamines during the maintenance phase of atopic dermatitis.
Acronym
A study to evaluate the efficacy of proactive therapy with topical agents and antihistamines during the maintenance phase of atopic dermatitis.
Scientific Title
A study to evaluate the efficacy of proactive therapy with topical agents and antihistamines during the maintenance phase of atopic dermatitis.
Scientific Title:Acronym
A study to evaluate the efficacy of proactive therapy with topical agents and antihistamines during the maintenance phase of atopic dermatitis.
Region
| Japan |
Condition
Condition
atopic dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the efficacy of a combination of proactive therapy with topical agents and prophylactic administration of antihistamines during the remission maintenance phase of treatment for atopic dermatitis, and to establish proactive therapy with a combination of topical agents and oral antihistamines.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Remission maintenance rate
Key secondary outcomes
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
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Proactive therapy with topical agents alone.
Interventions/Control_2
Proactive therapy with topical agents plus antihistamines.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed with atopic dermatitis and who had moderate or severe atopic eczema in the recent 12 weeks.
2) Patients with less than mild score who are well controlled with standard therapy defined in the JDA guideline.
*controlled without steroids anc tacrolimus treatment.
*TARC level is less than 700pg/mL
3) Patients providing written consent after receiving explanation regarding the details of this study.
4) Patients aged 16 years or older at enrollment; for those under the age of 20 years, consent from their legal guardians (e.g., their parents) is required.
Key exclusion criteria
1) Patients who have the history of hypersensitivity to any of the study drug.
2) Pregnant or possibly pregnant women, or breastfeeding women. Women who wish to become pregnant during study participation.
3) Patients who are judged inappropriate to participate in the study by the investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Kawashima |
Organization
Tokyo Woman's Medical University
(Non-Profit Organization Health Institute Research of Skin)
Division name
Department of Dermatology
Zip code
Address
8-1 Kawada-cho, Shinjyuku-ku, Tokyo, Japan
TEL
03-3353-8111
m-kawash@derm.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naomi Kanazawa |
Organization
EBC&M LLC.
Division name
Project planning & Development department
Zip code
Address
CROSS OFFICE MITA 9F 5-29-20, Shiba, Minato-ku, Tokyo, Japan
TEL
03-6435-3833
Homepage URL
kanazawa@ebc-m.com
Sponsor or person
Institute
Non-Profit Organization Health Institute Research of Skin
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization
Profit organization
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
| 2015 | Year | 05 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2014 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 23 | 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
| 2015 | Year | 05 | Month | 13 | Day |
Last modified on
| 2017 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019782
