Tokyo, March 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060921) titled 'Evaluation of the perceived improvement in atopic dermatitis symptoms with the application of skincare products' on March 23.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Miura Clinic, Medical Corporation Kanonkai
Condition:
Condition - Atopic dermatitis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Apply the skincare product continuously for 8 weeks and evaluate the perceived improvement (satisfaction) in atopic dermatitis symptoms.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Apply test products for 8 weeks
Interventions/Control_2 - Apply placebo products for 8 weeks
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - (1) Men and women aged 20 and over with symptoms of atopic dermatitis on the face or body
(2) Subjects with an EASI score of 1.1 or higher
(3) Subjects who have not undergone treatment for atopic dermatitis for a certain period and have not used alternative therapies
(4) Subjects who have received a thorough explanation of the purpose and content of the trial, has the capacity to consent, understands it well, voluntarily agrees to participate, and has given written consent to participate in the trial
Key exclusion criteria - (1) Subjects who used topical treatments for atopic dermatitis within 4 weeks prior to the screening test date
(2) Subjects who received systemic administration (oral or intravenous) of steroids, immunosuppressants, or JAK inhibitors within 8 weeks prior to the screening test date Subjects who have undergone gastrointestinal surgery
(3) Subjects who regularly take anti-inflammatory oral medications or anti-allergy drugs
(4) Subjects who have previously received treatment with biological agents or phototherapy
(5) Subjects with a history of mental illness, diabetes, liver disease, kidney disease, gastrointestinal disease, heart disease, respiratory disease, peripheral vascular disorder, or other serious illnesses
(6) Subjects who have undergone gastrointestinal surgery
(7) Subjects with an ongoing medical condition
(8) Subjects of allergies to cosmetics or food (Including those who have experienced skin reactions such as rashes from cosmetics within the past year)
(9) Subjects who have significant abnormalities on the skin of the test site, or who have severe atopic dermatitis symptoms
(10) Women who wish to become pregnant during participation in this trial, women who are pregnant (including the possibility of being pregnant), or women who are breastfeeding
(11) Subjects whose skin condition changes drastically due to menstrual irregularities or menstruation
(12) Individuals who engage in intense sports and subjects who are on a diet
(13) Subjects with extremely irregular eating habits
(14) Subjects working night shifts and rotating day-night shifts
(15) Subjects who, within 4 weeks prior to the screening test date, have been exposed to ultraviolet rays through prolonged outdoor work, exercise, swimming in the sea, leisure activities, or who plan to be exposed to UV rays during the study period beyond their normal daily activities
(16)to(24)are listed in the "Other related information" column
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 19 Day
Date of IRB - 2026 Year 02 Month 26 Day
Anticipated trial start date - 2026 Year 03 Month 24 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=R000069658
Disclaimer: Curated by HT Syndication.
