UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051817 |
|---|---|
| Receipt number | R000059124 |
| Scientific Title | An observational study to investigate the efficacy and safety of maintenance therapy with difamilast for patients with atopic dermatitis |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2025/03/19 09:36:12 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
An observational study to investigate the efficacy and safety of maintenance therapy with difamilast for patients with atopic dermatitis
Acronym
271-JMA-22003
Scientific Title
An observational study to investigate the efficacy and safety of maintenance therapy with difamilast for patients with atopic dermatitis
Scientific Title:Acronym
271-JMA-22003
Region
| Japan |
Condition
Condition
Patients with atopic dermatitis in the remission maintenance phase
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this research is to investigate the time to relapse from the start of the treatment during the remission maintenance phase, and the details of the treatment and safety information during the period in patients with atopic dermatitis who started the treatment during the remission maintenance phase with difamilast ointment or an emollient.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Number of days from the start day of remission maintenance therapy to relapse of atopic dermatitis
Key secondary outcomes
Number of days from the start day of remission maintenance therapy to relapse of atopic dermatitis by site, Number of days of topical corticosteroids use from the start day of remission maintenance therapy to the end-of-trial visit
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
| 16 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients who have given written informed consent to participation in this research, 2.Patients aged 16 to 70 years on the day of informed consent with sufficient ability to make decisions regarding being investigated in the research,3.Patients with atopic dermatitis who underwent remission induction therapy using tacrolimus ointment, delgocitinib ointment, and topical corticosteroids classified as `very strong` or less in the Japanese guidelines for atopic dermatitis within 26 weeks before the start of treatment in the remission maintenance phase from mild to moderate conditions based on `Guide for Severity of Atopic Dermatitis` developed by the Health and Labour Sciences Research Group. 4.Patients with atopic dermatitis with IGA score <= 1 at the start of the treatment in the remission maintenance phase and at least 2 consecutive assessments within 14 to 60 days immediately before the start of the treatment,5.Patients who have started the following treatment within 30 days before informed consent. However, any treatment must be performed independently from participation in this research, and informed consent may be obtained on the day after the start of the treatment or later. Patients who experienced relapse of atopic dermatitis during the period from the start of remission maintenance therapy to informed consent, those who received additional treatment for relapse, and those receiving additional treatment for relapse during the research period are included as the subjects of this research. The content of scalp treatment does not matter.Difamilast group:Patients who have been treated with difamilast in accordance with the Japanese package insert.Use of emollients for areas without skin eruption other than the areas where difamilast is applied is allowed. For emollients, any type or dosage form can be used.Emollient group:Patients who have been receiving remission maintenance therapy using emollients as instructed by a physician.
Key exclusion criteria
1.Patients with active or recurrent skin diseases other than atopic dermatitis that require treatment, 2.Patients with a history of treatment with difamilast at the research site (only in the difamilast group) before the start of the treatment in the remission maintenance phase,3.Patients who received systemic steroids, topical steroids (excluding the scalp) classified as `strongest` in the Japanese guidelines for atopic dermatitis, immunosuppressants, biological products, etc. within 26 weeks before the start of the treatment in the remission maintenance phase, 4.Patients who received phototherapy (UVB, narrow band UVB, PUVA, etc.) within 4 weeks before the start of the treatment in the remission maintenance phase, 5.Women who are pregnant or may possibly be pregnant and lactating women. Patients who wish to become pregnant during the research period, 6.Patients who have participated in a clinical trial or interventional clinical research within 4 weeks before the start of the treatment in the remission maintenance phase, 7.Patients with skin eruption with severe inflammation in >= 10% of body surface area within 4 weeks before the start of the treatment in the remission maintenance phase, 8.Patients whose treatment for atopic dermatitis was changed (discontinuation of the administration of the investigational drug, initiation of proactive therapy with TCSs or TCIs) during the period from the start of the treatment in the remission maintenance phase to the day of informed consent, 9.Other patients judged by the principal investigator to be ineligible for the research
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Toshiya |
| Middle name | |
| Last name | Asai |
Organization
Asai Dermatology Clinic
Division name
-
Zip code
240-0013
Address
1-14, Katabira-cho, Hodogaya-ku, Yokohama-shi, Kanagawa
TEL
045-334-3412
tos@asai-hifuka.com
Public contact
Name of contact person
| 1st name | Chiho |
| Middle name | |
| Last name | Shibata |
Organization
RPM Co.,Ltd.
Division name
Project Promotion Dep.
Zip code
1600023
Address
5F JRE Nishi-Shinjuku Terrace, 3-2-4, Nishi-Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-5325-5821
Homepage URL
rpm2023-com@rpmedical.co.jp
Sponsor or person
Institute
Asai Dermatology Clinic
Institute
Department
Personal name
Toshiya Asai
Funding Source
Organization
Otsuka Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asai Dermatology Institutional Review Board
Address
1-14, Katabira-cho, Hodogaya-ku, Yokohama-shi, Kanagawa
Tel
0355430196
jumukyoku@smo-msr.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
あたご皮フ科（東京都）、三田皮膚科（東京都）、しもだ皮ふ科クリニック（東京都）、医療法人社団路是りくぎえん皮膚科（東京都）、医療法人社団精華会ミルディス皮フ科（東京都）、まるやま皮膚科クリニック（東京都）、糀谷皮膚科（東京都）、松山皮膚科（東京都）、医療法人社団紬心会池袋西口ふくろう皮膚科クリニック（東京都）、医療法人QUEEN'S SQUARE MEDICAL FACILITIESクイーンズスクエア皮膚科・アレルギー科（神奈川県）、医療法人社団健祐会あざみ野皮膚科（神奈川県）、医療法人社団浅井皮膚科クリニック（神奈川県）、西村たくや皮膚科クリニック（大阪府）、医療法人医泉会泉ヶ丘皮フ科・内視鏡クリニック（大阪府）、医療法人一華会てらお皮ふ科・アレルギー科クリニック（福岡県）、医療法人みあけ皮ふ科（福岡県）、医療法人佑諒会千里中央花ふさ皮ふ科（大阪府）、医療法人社団誠祐会秋葉原スキンクリニック（東京都）、広尾皮フ科クリニック（東京都）、医療法人社団高典会飯田橋クリニック（東京都）、医療法人社団眞幸会四谷三丁目皮膚科（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | 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
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 | 07 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The objective of this research is to investigate the time to relapse from the start of the treatment during the remission maintenance phase, and the details of the treatment and safety information during the period in patients with atopic dermatitis who started the treatment during the remission maintenance phase with difamilast ointment or an emollient.
Management information
Registered date
| 2023 | Year | 08 | Month | 03 | Day |
Last modified on
| 2025 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059124
