Tokyo, March 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061084) titled 'The Effects of Continuous Use of Three Cosmetic Products on Skin with Mild Atopic Dermatitis Symptoms' on March 27.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - No treatment
Primary Sponsor:
Institute - Japan Clinical Trial Association
Condition:
Condition - Healthy adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Effects of continued use of the test articles on skin with mild atopic dermatitis symptoms
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - The test articles were used for 4 weeks on only one side of the face and one side of the arm (three articles on the face-soap, lotion, and serum-and only the serum on the arm)
Interventions/Control_2 - Leave the other side of the face and the other side of the arm untreated
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - 1.Subjects diagnosed with atopic dermatitis or with a history of the condition
2.Subjects with a POEM score of 5-9 for the face and arms
3.Subjects whose symptoms have remained relatively stable over the past month and who have not started any new treatments or changed their current treatment regimen
Key exclusion criteria - 1.Individuals with excessive exudate, or those with extensive severe inflammation, bleeding, or excoriations
2.Individuals who have regularly used topical steroids, topical immunomodulators, or tacrolimus ointment within the past 2 weeks; individuals who have used oral steroids or immunosuppressants within the past 4 weeks; or individuals who have used biologics within the past 6 months
3.Individuals with skin conditions other than contact dermatitis, psoriasis, or atopic dermatitis on the study sites
4.Individuals who have undergone cosmetic medical procedures on the study sites
5.Pregnant or breastfeeding women, or women planning to become pregnant
6.Individuals undergoing hormone replacement therapy
7.Individuals with severe liver or kidney disease
8.Individuals who have undergone phototherapy within the past month
9.Individuals with an allergy to any component of the test product
10.Individuals who have participated in a human clinical trial within the past month, or who plan to do so during the study period
Target Size - 8
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 10 Day
Date of IRB - 2026 Year 02 Month 26 Day
Anticipated trial start date - 2026 Year 03 Month 27 Day
Last follow-up date - 2026 Year 04 Month 24 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069888
Disclaimer: Curated by HT Syndication.