Tokyo, Dec. 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059941) titled 'A Clinical Use Study of Pure Golden Jojoba Oil in Patients with Atopic Dermatitis and Dry Skin' on Dec. 3.

Study Type: Interventional

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

Primary Sponsor: Institute - Non-Profit Organization Health Institute Research of Skin

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

Objective: Narrative objectives1 - The objective of this study is to evaluate the moisturizing efficacy and safety of Pure Golden Jojoba Oil when applied to dry skin in patients with atopic dermatitis (AD). Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - The test article (Pure Golden Jojoba Oil) shall be topically applied to the unilaterally assigned area on either the forearm or lower leg, twice per day (in the morning and evening), for a duration of four weeks. The corresponding contralateral area will serve as the untreated control. Assessments will be conducted in a blinded manner by an evaluator who is unaware of the assignment codes (evaluator-blinded).

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. Patients with AD who have maintained a remission state*1 for at least four weeks. *1 Definition of remission: The overall condition remains stable with an IGA score of 0 or 1. The remission state can be maintained mainly with moisturizers, while anti-inflammatory topical agents*2 are used only on limited areas of the body. The use of oral JAK inhibitors or biologics is permitted. *2 Anti-inflammatory topical agents- topical corticosteroids, tacrolimus ointment, delgocitinib ointment, difamilast ointment, and tapinarof cream. 3. Patients presenting with comparable skin dryness on both sides of the lower legs or forearms -evaluation sites.

Selection of Evaluation Sites Both the left and right sides of either the lower legs or forearms will be designated as evaluation sites. The application site and the non-application site of the test product will be randomly assigned to the left or right side. If dryness is observed on both the lower legs and forearms, the lower legs will be selected as the evaluation sites. Key exclusion criteria - Patients with inflammation at the evaluation site who are using anti-inflammatory topical medications Patients with a history of contact dermatitis to cosmetics or similar products Other patients deemed ineligible for the study by the principal investigator Target Size - 30

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 10 Month 29 Day Date of IRB - 2025 Year 11 Month 28 Day Anticipated trial start date - 2025 Year 12 Month 02 Day Last follow-up date - 2026 Year 05 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068074

Disclaimer: Curated by HT Syndication.