Tokyo, Feb. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060588) titled 'Use Test of Sunscreen Products (Cosmetics) for Children with Dry Skin Symptoms and Their Parents' on Feb. 5.

Study Type: Interventional

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

Primary Sponsor: Institute - Takano Medical Clinic

Condition: Condition - photosensitivity, atopic dermatitis, infantile xerotic eczema, infantile eczema Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - As research on the effects of sunlight, particularly ultraviolet (UV) radiation, on the human body advances, awareness of the necessity for UV protection is also growing. For individuals with skin conditions, UV radiation can be a factor worsening symptoms, making UV countermeasures crucial. In this study, newly developed sunscreen products (cosmetics) will be used by children with skin conditions such as photosensitivity, atopic dermatitis, infantile xerotic eczema, and infantile eczema, along with their guardians.By providing appropriate guidance on sunscreen use to parents, we aim to deepen their understanding of UV protection, improve treatment adherence, and ensure proper application to children. We will confirm the safety and efficacy of the product, including whether it can be used without issue as part of daily skincare and whether it exacerbates skin symptoms in children or their parents. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - The study doctor selects the test product to be used from among the test samples (six types of sunscreen agents) based on the required level of light-blocking effectiveness and the action wavelength (UVB, UVA, visible light) for each disease, as well as the characteristics of the test product (such as light-blocking effect and user experience).

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Children diagnosed with photosensitivity, atopic dermatitis, infantile xerotic eczema, or infantile eczema, for whom the use of this investigational drug is deemed therapeutically beneficial, and their parents. Key exclusion criteria - (I)Individuals with a history of severe skin reactions caused by sunscreen use (II)Individuals with rashes or other conditions on the application site that make application of the test product inappropriate (III)Cases where interference between the test product and other topical treatments is anticipated (IV)Individuals who, in principle, cannot attend a follow-up examination 2 weeks later or at the end of the trial (4 weeks later) (V)Individuals deemed unsuitable for participation in this study by the study physician Target Size - 80

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2006 Year 01 Month 09 Day Anticipated trial start date - 2026 Year 02 Month 05 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=R000068867

Disclaimer: Curated by HT Syndication.