Clinical Trial: 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 (Japan)

Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062216) titled 'Randomized Split-Face Study Comparing Delgocitinib and Hydrocortisone Butyrate on Skin Barrier Function in Children With Facial Atopic Dermatitis' on Aug. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - Active

Primary Sponsor: Institute - Juntendo University

Condition: Condition - Pediatric Atopic Dermatitis Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

Eligibility: Age-lower limit - 2 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 Size - 30

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069481

Disclaimer: Curated by HT Syndication.