UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055543 |
|---|---|
| Receipt number | R000063475 |
| Scientific Title | A survey of the incidence of skin infections in patients with atopic dermatitis treated with topical medications -A cohort study using detailed medical fee data from health insurance associations and national health insurance associations- |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2025/09/19 09:42:42 |
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Basic information
Public title
A survey of the incidence of skin infections in patients with atopic dermatitis treated with topical medications
Acronym
A survey of the incidence of skin infections in patients with atopic dermatitis treated with topical medications
Scientific Title
A survey of the incidence of skin infections in patients with atopic dermatitis treated with topical medications
-A cohort study using detailed medical fee data from health insurance associations and national health insurance associations-
Scientific Title:Acronym
A survey of the incidence of skin infections in patients with atopic dermatitis treated with topical medications
-A cohort study using detailed medical fee data from health insurance associations and national health insurance associations-
Region
| Japan |
Condition
Condition
atopic dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the incidence of skin infections in patients with atopic dermatitis treated with difamilast ointment using the person-year method with topical steroid control groups and non-steroid control groups (tacrolimus ointment, delgocitinib ointment) in an exploratory manner.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Skin infections (folliculitis, acne, impetigo, herpes infection, Kaposi's varicelliform eruption, tinea, warts, candidiasis, cellulitis, erysipelas, molluscum contagiosum, carbuncle, furuncle)
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Cases in which atopic dermatitis (ICD10 code: L20: Atopic dermatitis) was diagnosed during the inclusion period, and the subject drug (difamilast ointment, topical steroids (by rank), non-steroids (tacrolimus ointment, delgocitinib ointment)) was started in the same month
2.Cases of patients under 75 years of age
3.Cases for which observation is possible for 180 days before the index date (cases for which there is an entry in the insured person register)
Key exclusion criteria
1.Cases where any skin infection (diseases defined as skin infections in 7.2.1) has occurred within 180 days prior to the start of drug administration Cases where any skin infection (diseases defined as skin infections in 7.2.1) has occurred within 180 days prior to the start of drug administration
2.Patients diagnosed with diabetes (E10-E14) within 180 days prior to the start of administration
3.Patients using immunosuppressants (oral and injectable) within 180 days prior to the start of administration
Target sample size
6000
Research contact person
Name of lead principal investigator
| 1st name | Miyuki |
| Middle name | |
| Last name | Matsukawa |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Medical Affairs
Zip code
540-0021
Address
3-2-27 Otedori, Chuo-ku, Osaka 540-0021, Japan
TEL
06-6943-7722
Matsukawa.Miyuki@otsuka.jp
Public contact
Name of contact person
| 1st name | Miyuki |
| Middle name | |
| Last name | Matsukawa |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Medical Affairs
Zip code
540-0021
Address
3-2-27 Otedori, Chuo-ku, Osaka 540-0021, Japan
TEL
06-6943-7722
Homepage URL
Matsukawa.Miyuki@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka 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
Otsuka Pharmaceutical Co., Ltd. Research Ethics Committee, Research Division
Address
463-10 Kagasuno, Kawauchi-cho, Tokushima-shi, Tokushima 771-0192
Tel
088-665-2126
Suzuki.Takashi@otsuka.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
| 2024 | Year | 10 | Month | 01 | 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
175063
Results
In this study, in patients with atopic dermatitis, the difamilast ointment group tended to have a slightly higher incidence of overall skin infections and acne than the topical steroid group, but there were no major differences in other items.Also, there were no major differences in overall skin infections or individual skin infections between the difamilast ointment group and the non-steroid group.
Results date posted
| 2025 | Year | 07 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Of the 1,804 patients in the difamilast group, the 45,988 patients in the steroid group, and the 8,256 patients in the non-steroid group, the proportion of men was 40.2%, 48.3%, and 33.2%, and the mean ages were 26.3, 21.5, and 34.7, respectively.
Participant flow
Adverse events
Outcome measures
skin infection
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 07 | Month | 10 | Day |
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 03 | Month | 19 | Day |
Other
Other related information
To compare the incidence of skin infections in the use of difamilast ointment and topical steroids, and difamilast ointment and tacrolimus ointment/delgocitinib ointment.
Management information
Registered date
| 2024 | Year | 09 | Month | 19 | Day |
Last modified on
| 2025 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063475
