UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060189 |
|---|---|
| Receipt number | R000068845 |
| Scientific Title | Reduction of Economic burden and Life Impact in atopic dermatitis through comprehensive Evaluation For policy (RELIEF) Study |
| Date of disclosure of the study information | 2025/12/24 |
| Last modified on | 2025/12/24 11:42:13 |
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Basic information
Public title
A study to investigate the impact of new oral and injectable treatments for atopic dermatitis on patients, their families, and healthcare costs
Acronym
RELIEF Study
Scientific Title
Reduction of Economic burden and Life Impact in atopic dermatitis through comprehensive Evaluation For policy (RELIEF) Study
Scientific Title:Acronym
RELIEF Study
Region
| Japan |
Condition
Condition
Atopic dermatitis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the societal value of novel systemic therapies for atopic dermatitis through comprehensive health economic assessment. In particular, the study will quantitatively assess caregiver burden, including loss of work productivity, reduced quality of life, and economic impact, which have not been adequately evaluated to date.
Basic objectives2
Others
Basic objectives -Others
Health economic evaluation
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Caregiver work productivity (WPAI-AD-CG), health-related quality of life (patients: EQ-5D-Y-3L, caregivers: EQ-5D-5L), healthcare costs (direct and indirect costs)
Key secondary outcomes
Clinical improvement of atopic dermatitis (EASI, POEM, NRS), quality of life improvement (patients: CDLQI, caregivers: DFI)
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
| 4 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients with atopic dermatitis aged 4 to 15 years
(2) Patients with EASI score of 16 or higher
(3) Patients judged by physicians to be eligible for novel systemic therapy
(4) Patients and caregivers who provided written informed consent
Key exclusion criteria
(1) Patients receiving or scheduled to receive biologics or JAK inhibitors for conditions other than atopic dermatitis (chronic spontaneous urticaria, seasonal allergic rhinitis, eosinophilic granulomatosis with polyangiitis, bronchial asthma, chronic rhinosinusitis with nasal polyps, prurigo nodularis)
(2) Patients receiving or scheduled to receive immunosuppressants other than novel systemic therapies (oral corticosteroids, cyclosporine, etc.)
(3) Patients with serious underlying diseases other than allergic diseases at enrollment
(4) Patients who have already started novel systemic therapy
(5) Patients judged inappropriate for participation by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Kuwabara |
Organization
Mie National Hospital
Division name
Allergy Center
Zip code
514-0125
Address
357 Osato-kubota, Tsu, Mie, Japan
TEL
+81592322531
kuwa2yu@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Kuwabara |
Organization
Mie National Hospital
Division name
Allergy Center
Zip code
514-0125
Address
357 Osato-kubota, Tsu, Mie, Japan
TEL
+81592322531
Homepage URL
kuwa2yu@yahoo.co.jp
Sponsor or person
Institute
Mie National Hospital
Institute
Department
Personal name
Yu Kuwabara
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mie National Hospital
Address
357 Osato-kubota, Tsu, Mie, Japan
Tel
+81592322531
kuwa2yu@yahoo.co.jp
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
国立病院機構三重病院(三重県)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 24 | 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
| 2025 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 24 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective observational study. The study compares two groups: patients who consent to initiate novel systemic therapy (biologics or JAK inhibitors) and patients who prefer to continue conventional therapy. The study evaluates the impact on caregiver work productivity, quality of life, and healthcare costs.
Management information
Registered date
| 2025 | Year | 12 | Month | 24 | Day |
Last modified on
| 2025 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068845
