Tokyo, Sept. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062905) titled 'Gentle Under-wrap Application for Relief of Dermatitis Study' on Sept. 14.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Dokkyo Medical University

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

Objective: Narrative objectives1 - To determine whether adding dry wrap therapy using commercially available bandages to the standard treatment regimen for pediatric patients with atopic dermatitis results in a significant improvement in the severity of atopic dermatitis after 4 weeks, compared with standard treatment alone. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Dry Wrap Therapy Interventions/Control_2 - Standard Treatment

Eligibility: Age-lower limit - 1 years-old = Gender - Male and Female Key inclusion criteria - 1. Children aged 1 year or older and 15 years or younger who have been diagnosed with atopic dermatitis by a physician according to the UK Working Party criteria. 2. Children who have been receiving appropriate standard anti-inflammatory treatment for atopic dermatitis for at least one month prior to study screening. 3. Children with obvious symptoms of atopic dermatitis on their limbs and a vIGA-AD score of 1 or higher. 4. Children whose parents or guardians are able to ensure compliance with treatment involving ointments and bandaging. 5. Children for whom neither the child nor the parent or guardian has any difficulty understanding Japanese. 6. Children for whom a sufficient written explanation of this study was provided and written informed consent was obtained from a parent, guardian, or other authorized representative of their own free will. Note that for children in elementary school or older, the child's own free will consent is required. Key exclusion criteria - 1. Children with a history of severe skin infections. 2. Children with suspected active localized skin infections (such as cellulitis or impetigo) at the start of the study, or children with concurrent infections requiring systemic administration of antibiotics. 3. Children with serious underlying medical conditions (such as congenital heart disease, severe neuromuscular disorders, or immunodeficiency) for whom the attending physician determines that participation in the study would pose a safety risk. 4. Children for whom the attending physician determines that the application of bandages would increase the absorption rate of the topical medication, thereby raising the risk of adverse reactions. 5. Children for whom regular outpatient visits during the study period are deemed difficult. Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 15 Day Anticipated trial start date - 2026 Year 10 Month 01 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071873

Disclaimer: Curated by HT Syndication.