Clinical Trial: Real-World Safety and Exploratory Effectiveness of Adjunctive Use of a Japanese Quasi-Drug Skin Lotion, Product A, in Patients with Atopic Dermatitis (Japan)

Tokyo, July 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062395) titled 'Real-World Safety and Exploratory Effectiveness of Adjunctive Use of a Japanese Quasi-Drug Skin Lotion, Product A, in Patients with Atopic Dermatitis' on July 29.

Study Type: Interventional

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

Primary Sponsor: Institute - Kindai university

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

Objective: Narrative objectives1 - To exploratorily evaluate the real-world safety of adjunctive use of Product, which is classified as a quasi-drug under the Pharmaceuticals and Medical Devices Act of Japan, as well as changes in skin condition, pruritus, and related outcome measures, in patients with atopic dermatitis receiving standard treatment. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Product A will be used for 6 months in this study. Participants will apply the product uniformly to the face, trunk, and extremities twice daily, in the morning and after bathing. The recommended amount per application will be 0.4 mL/kg body weight; for example, a participant weighing 50 kg will use approximately 20 mL per application. Interventions/Control_2 - Standard-treatment continuation group without Product A

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients aged 18 years or older with atopic dermatitis 2. Individuals who have provided written informed consent to participate in the study Key exclusion criteria - 1. Patients with a concomitant skin infection at the time of enrollment that is considered likely to materially affect study assessments 2. Patients whose topical treatment for atopic dermatitis has been substantially changed within 2 weeks before enrollment 3. Patients in whom systemic treatment for atopic dermatitis, including systemic corticosteroids, immunosuppressants, biologic agents, or Janus kinase (JAK) inhibitors, has been initiated or increased in dose within 4 weeks before enrollment 4. Patients scheduled to initiate or increase the dose of any of the above systemic treatments during the study period 5. Patients with a history of hypersensitivity to any component of Product A 6. Patients who are pregnant, breastfeeding, or planning to become pregnant during the study period and are considered unsuitable for participation by the principal investigator or a sub-investigator 7. Patients otherwise considered unsuitable for participation in the study by the principal investigator or a sub-investigator Target Size - 136

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 07 Month 09 Day Date of IRB - 2026 Year 07 Month 22 Day Anticipated trial start date - 2026 Year 07 Month 28 Day Last follow-up date - 2027 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071375

Disclaimer: Curated by HT Syndication.