Tokyo, May 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061611) titled 'Effects of the Vitamin C Derivative K3A on Symptoms of Atopic Dermatitis' on May 18.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Miura Clinic, Medical Corporation Kanonkai
Condition:
Condition - Atopic dermatitis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the therapeutic efficacy and remission maintenance effects of the active ingredient on atopic dermatitis symptoms through continuous application of the skincare product for 7 consecutive days
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Apply test products for 7 days
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - (1) Men and women aged 20 to 59 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) and beyond are described in Other related information.
Target Size - 4
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 22 Day
Date of IRB - 2026 Year 04 Month 23 Day
Anticipated trial start date - 2026 Year 05 Month 19 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=R000070444
Disclaimer: Curated by HT Syndication.
