UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056704 |
|---|---|
| Receipt number | R000064818 |
| Scientific Title | Observation of Changes in Patients' Topical Medication Application Amount Using the 'Ointment Diary' |
| Date of disclosure of the study information | 2025/01/15 |
| Last modified on | 2025/01/14 00:53:46 |
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Basic information
Public title
Observation of Changes in Patients' Topical Medication Application Amount Using the 'Ointment Diary'
Acronym
The Ointment Diary Study
Scientific Title
Observation of Changes in Patients' Topical Medication Application Amount Using the 'Ointment Diary'
Scientific Title:Acronym
The Ointment Diary Study
Region
| Japan |
Condition
Condition
atopic dermatitis
Classification by specialty
| Clinical immunology | Pediatrics | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In patients with atopic dermatitis, observe whether there is a difference in the amount of application of prescribed topical medications between those who use an "application diary" in which patients and their families record the number of applications of prescribed topical medications and those who do not.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare the amount of topical medications used by patients with atopic dermatitis who used the "Application Diary" and those who did not use it after 1-4 weeks of use.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The intervention period is 1 to 4 weeks, the intervention to the subject is to instruct the subject to record the "application diary", the number of interventions is the first time, and if the subject requests an explanation on the recording method, etc., an explanation will be given each time.
Interventions/Control_2
The duration of the intervention is 1-4 weeks, and the only intervention for the subject is not to suggest the recording of an "application diary".
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
| Not applicable |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with atopic dermatitis between 0 and 18 years of age, regardless of gender.
Key exclusion criteria
If you do not understand and consent to this research
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yumiko |
| Middle name | |
| Last name | SAITO |
Organization
Saito Clinic for Asthma and Allergy children
Division name
hospital department
Zip code
524-0022
Address
1-12-12 Moriyama, Moriyama City, Shiga Prefecture, Japan
TEL
077-582-3110
doctor@children.or.jp
Public contact
Name of contact person
| 1st name | Naruo |
| Middle name | |
| Last name | SAITO |
Organization
Saito Clinic for Asthma and Allergy children
Division name
hospital department
Zip code
524-0022
Address
1-12-12 Moriyama, Moriyama City, Shiga Prefecture, Japan
TEL
077-582-3110
Homepage URL
doctor@children.or.jp
Sponsor or person
Institute
Saito Clinic for Asthma and Allergy children
Institute
Department
Personal name
Funding Source
Organization
Saito Clinic for Asthma and Allergy children
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Medical Corporation Fujishirokai Saito Clinic for Asthma and Allergy children
Address
1-12-12 Moriyama, Moriyama City, Shiga Prefecture, Japan
Tel
077-582-3110
doctor@children.or.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
| 2025 | Year | 01 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 14 | Day |
Last modified on
| 2025 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064818
