Tokyo, Sept. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062773) titled 'A Study of the Safety and User Experience of NAP4 Skin Lotion' on Sept. 2.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - wakayama medical university

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

Objective: Narrative objectives1 - The objective of this study is to exploratorily evaluate the safety and user experience of NAP4 skin lotion during 4 weeks of use in adult patients with atopic dermatitis. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Participants will topically apply NAP4 skin lotion containing arginine aminophosphonobutyrate for 4 weeks. Safety and user experience during the intervention period will be evaluated.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Individuals aged 20 years or older at the time of enrollment. 2. Patients who are receiving outpatient care at our Department of Dermatology and have been diagnosed with atopic dermatitis. 3. Individuals who have received sufficient explanation of the study and have provided written informed consent of their own free will. 4. Individuals who are able to complete the questionnaires during the study period and undergo assessments at baseline and 4 weeks. Key exclusion criteria - 1. Individuals with a history of contact dermatitis or similar adverse skin reactions caused by any component of the investigational product or similar ingredients. 2. Individuals with an active severe skin infection at the study site at the time of study initiation. 3. Individuals who have started or changed any new topical or systemic treatment considered likely to affect the study assessments within 2 weeks before study initiation. 4. Individuals who are considered unlikely to complete follow-up through the 4-week assessment. 5. Pregnant or breastfeeding individuals for whom the principal investigator determines that particular caution is required from a safety assessment perspective. 6. Any other individuals whom the principal investigator considers unsuitable for participation in the study for safety reasons. Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 09 Month 02 Day Anticipated trial start date - 2026 Year 09 Month 14 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071865

Disclaimer: Curated by HT Syndication.