Tokyo, Aug. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062623) titled 'Study to Evaluate the Moisturizing Effects of Continuous Use of the Test Product on Non-Lesional Skin in Subjects with Atopic Dermatitis' on Aug. 19.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Active
Primary Sponsor:
Institute - Inforward, inc
Condition:
Condition - Healty volunteers
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The objective is to evaluate the moisturizing effect of the continuous use of two ceramide-like compounds -containing lotions for three weeks in individuals with atopic dermatitis who exhibit dryness on the inner surfaces of both forearms.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Apply the test product daily for 3 weeks.
Interventions/Control_2 - Apply the product daily for three weeks.
Eligibility:
Age-lower limit - 20
years-old
Gender - Female
Key inclusion criteria - Those who meet all of the following conditions will be selected.
1)Women aged 20 to under 60
2)Individuals with mild symptoms of atopic dermatitis*1
3)Individuals exhibiting dryness on the inner surfaces of both forearms.
4)Those who have expressed their willingness to participate in the study, understood the explanation, and can provide written consent to participate in the study.
*1: Based on the "Criteria for Atopic Dermatitis Severity" in the Japanese Dermatological Association's *Clinical Practice Guidelines for Atopic Dermatitis 2024*.
Key exclusion criteria - Those who meet any of the following criteria will be excluded.
1) Individuals with atopic dermatitis of moderate severity or worse (severity grade 1 or higher)
2) Individuals taking oral steroids, antihistamines, anti-allergy medications, immunosuppressants, or tranquilizers.
3) Individuals who have previously experienced severe allergic symptoms due to the use of topical preparations, cosmetics, quasi-drugs, or other products.
4) Individuals with a serious illness who are considered unsuitable for enrollment.
5) Individuals currently undergoing treatment or attending medical appointments for a medical condition (excluding the common cold or dental care).
6) Individuals who have a family member working for a pharmaceutical or cosmetics company.
7) Individuals participating in other studies involving clinical trials, cosmetics, quasi-drugs, or foods, or those who have participated in a clinical trial within the past four weeks.
8) Others who have been determined ineligible by investigator.
Target Size - 10
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 04 Day
Anticipated trial start date - 2026 Year 02 Month 20 Day
Last follow-up date - 2026 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071683
Disclaimer: Curated by HT Syndication.
