UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062216 |
|---|---|
| Receipt number | R000069481 |
| Scientific Title | A 24-Week, Randomized, Evaluator-Blinded, Split-Face Trial Comparing Delgocitinib 0.25% and Hydrocortisone Butyrate 0.1% on Transepidermal Water Loss and Stratum Corneum Biomarkers in Children With Bilateral Facial Atopic Dermatitis |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/07/12 15:44:06 |
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Basic information
Public title
Randomized Split-Face Study Comparing Delgocitinib and Hydrocortisone Butyrate on Skin Barrier Function in Children With Facial Atopic Dermatitis
Acronym
Randomized SPLIT-face Trial in Atopic Dermatitis
Scientific Title
A 24-Week, Randomized, Evaluator-Blinded, Split-Face Trial Comparing Delgocitinib 0.25% and Hydrocortisone Butyrate 0.1% on Transepidermal Water Loss and Stratum Corneum Biomarkers in Children With Bilateral Facial Atopic Dermatitis
Scientific Title:Acronym
SPLIT-AD
Region
| Japan |
Condition
Condition
Pediatric Atopic Dermatitis
Classification by specialty
| Pediatrics | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether barrier recovery trajectories during proactive maintenance differ between topical delgocitinib and hydrocortisone butyrate, and whether within-subject differences in transepidermal water loss (TEWL) parallel differences in stratum corneum ceramide composition and IL-33.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Between-side difference in transepidermal water loss TEWL, at Week 24 -delgocitinib side minus hydrocortisone butyrate side-
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Delgocitinib 0.25% ointment applied twice daily for 4 weeks (reactive phase), followed by twice-weekly proactive maintenance for 20 weeks to one randomized facial side.
Interventions/Control_2
Hydrocortisone butyrate 0.1% applied to the contralateral facial side using the same schedule.
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
| 2 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Diagnosis of atopic dermatitis according to established criteria
Presence of bilateral symmetric facial lesions
Ability to undergo TEWL measurement
Written informed consent obtained from guardians
Key exclusion criteria
Active bacterial or viral facial infection
Systemic immunosuppressive therapy
Use of other topical immunomodulators during study period
Marked asymmetry in lesion severity between facial sides
Inability to comply with protocol
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Baba |
Organization
Juntendo University Shizuoka Hospital
Division name
Department of Pediatrics
Zip code
410-2295
Address
1129, Nagaoka, Izunokuni Shizuoka,Japan
TEL
0559483111
youbaba@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | kazuki |
| Middle name | |
| Last name | Miyabayashi |
Organization
Juntendo University Shizuoka Hospital
Division name
Department of Pediatrics
Zip code
410-2295
Address
1129 Nagaoka, Izuno-kuni, Shizuoka, Japan
TEL
0559483111
Homepage URL
shizuoka.rinri.sibu@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Special Research in Subsidies for ordinary expenses of private schools from The Promotion and Mutual Aid Corporation for Private Schools of Japan
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Shizuoka Hospital Good Clinical Practice Center
Address
1129 Nagaoka, Izuno-kuni, Shizuoka, Japan
Tel
055-948-3111
gcpjun@mtc.biglobe.ne.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
E 22-0186
Org. issuing International ID_1
Institutional Review Board of Juntendo University Shizuoka Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
https://osf.io/6aebx/files/n9ur8
Publication of results
Unpublished
Result
URL related to results and publications
https://osf.io/6aebx/files/uxnh3
Number of participants that the trial has enrolled
20
Results
Twenty subjects were enrolled, and 18 completed the 24-week study. At week 24, TEWL was 15.8 g/m2/h in the delgositinib group and 21.2 g/m2/h in the steroid group, with an intra-subject difference of -5.4 (95% CI -7.4 to -3.4, p < 0.001). The stratum corneum ceramide EOS/NS ratio was high, whilst stratum corneum IL-33 levels were low. No serious adverse events were observed.
Results date posted
| 2026 | Year | 07 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Among the 18 participants included in the analysis, the mean age was 8.2 +/- 3.4 years (range, 2-14 years), and 10 participants (56%) were male. Investigator Global Assessment scores were 2 in eight participants and 3 in ten participants. Baseline TEWL was 33.4 +/- 6.8 g/m2/h on the delgocitinib-assigned side and 34.2 +/- 7.2 g/m2/h on the corticosteroid-assigned side, with no significant within-subject difference (mean difference, -0.8 g/m2/h; p=0.42). Six participants (33%) had prior tacrolimus use. Median total IgE was 980 IU/mL, and the mean peripheral eosinophil count was 480 +/- 220/uL.
Participant flow
Thirty-two patients were screened, and 20 who met the eligibility criteria, including bilateral symmetric facial involvement, were enrolled. Eighteen participants (90%) completed the 24-week study. Two participants discontinued: one at Week 6 because of relocation and one at Week 10 because of an intercurrent illness unrelated to the study treatment. The primary analysis included the 18 participants who completed the Week-24 assessment.
Adverse events
No serious adverse events occurred. Transient application-site burning or stinging was observed on the delgocitinib-treated side in two participants (11%) and resolved spontaneously within one week. Folliculitis occurred on the hydrocortisone butyrate-treated side in two participants (11%) and resolved with topical treatment. No skin atrophy, telangiectasia, or application-site erythema was observed on either treatment side.
Outcome measures
The primary outcome was the within-subject difference in transepidermal water loss (TEWL) between the delgocitinib-treated cheek and the hydrocortisone butyrate-treated cheek at Week 24. Key secondary outcomes were the treatment-by-time interaction in TEWL during the proactive maintenance phase, the within-subject Week-24 difference in the stratum corneum ceramide EOS/NS ratio, and the within-subject Week-24 difference in stratum corneum IL-33 concentration. Exploratory outcomes included correlations between stratum corneum biomarkers and TEWL differences, clinical severity scores, serum biomarkers, and safety.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 04 | Month | 10 | Day |
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 05 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 12 | Day |
Last modified on
| 2026 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069481
