UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049841 |
|---|---|
| Receipt number | R000056775 |
| Scientific Title | Clinical Effects of Delgocitinib Ointment on Skin Barrier Dysfunction in Pediatric Atopic Dermatitis |
| Date of disclosure of the study information | 2022/12/22 |
| Last modified on | 2024/01/03 18:55:06 |
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Basic information
Public title
Clinical Effects of Delgocitinib Ointment on Skin Barrier Dysfunction in Pediatric Atopic Dermatitis
Acronym
Clinical Effects of Delgocitinib Ointment on Skin Barrier Dysfunction in Pediatric Atopic Dermatitis
Scientific Title
Clinical Effects of Delgocitinib Ointment on Skin Barrier Dysfunction in Pediatric Atopic Dermatitis
Scientific Title:Acronym
Clinical Effects of Delgocitinib Ointment on Skin Barrier Dysfunction in Pediatric Atopic Dermatitis
Region
| Japan |
Condition
Condition
Atopic Dermatitis
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical efficacy of topical delgocitinib on skin barrier dysfunction in atopic dermatitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in TEWL and SCH from baseline to 12 weeks
Key secondary outcomes
Change in TARC, SCCA2, EASI, pEASI and vIGA from baseline to 12 weeks
TEWL, SCH, and questionnaire scores for eczematous and non-eczematous areas at 12 weeks
TARC, SCCA2, EASI, pEASI and vIGA at 12 weeks
EIS results at baseline and at 12 weeks, and findings from tape stripping
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Corectim group
Colectim ointment twice a day, but Lidomex ointment can be used in case of eczema exacerbation.
Interventions/Control_2
Steroid group
Lidomex ointment twice daily, if eczema improves, patients may be switched to Proactive therapy. Protopic ointment may be used on the head and neck area.
Interventions/Control_3
Non-AD group
No treatment
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
| 6 | months-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Pediatric patients with atopic dermatitis who have eczema on the elbow fossa with vIGA-AD score of 2 or higher
Key exclusion criteria
(1) Patients with a history of use of group II or higher topical steroids or delgocitinib ointment on the forearm within 1 month
(2) Patients with signs of infection on the forearm
(3) Patients with a history of use of biological drugs within 1 year or who are going to use biological drugs during participation in the study
(4) Other patients deemed inappropriate as research subjects by the principal investigator
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Sakura |
| Middle name | |
| Last name | Sato |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Clinical Research Center for Allergy and Rheumatology
Zip code
252-0392
Address
18-1 Sakuradai, Minamiku, Sagamihara, Kanagawa
TEL
042-742-8311
ssakura8010@foodallergy.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Kawai |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Department of pediatrics
Zip code
252-0392
Address
18-1 Sakuradai, Minamiku, Sagamihara, Kanagawa
TEL
042-742-8311
Homepage URL
akawai-ykh@umin.ac.jp
Sponsor or person
Institute
National Hospital Organization Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
Torii Pharmaceutical Co.,Ltd
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
Sagamihara Hospital Ethics Committee of the National Hospital Organization
Address
18-1 Sakuradai, Minamiku, Sagamihara, Kanagawa
Tel
042-742-8311
makino.megumi.bn@mail.hosp.go.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 22 | 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
| 2022 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 20 | Day |
Last modified on
| 2024 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056775
| 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 |
