Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063021) titled 'Effectiveness of Moisturizing Skin Care in Patients with Diabetes Mellitus' on Oct. 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Oita University
Condition:
Condition - Type 2 diabetes mellitus
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effect of 8-week moisturizing skin care on stratum corneum hydration in patients with type 2 diabetes mellitus.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - In the type 2 diabetes mellitus group, a moisturizing skin care product is applied to the flexor forearm once or twice daily for 8 weeks.
Interventions/Control_2 - In the healthy adult group, a moisturizing skin care product is applied to the flexor forearm once or twice daily for 8 weeks.
Eligibility:
Age-lower limit - 18
years-old
<
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Adults aged 18 years or older who are either healthy or have type 2 diabetes mellitus. Patients with type 2 diabetes mellitus must have an HbA1c level of 6.5% or higher, and healthy participants must not have a diagnosis of type 2 diabetes mellitus.
Key exclusion criteria - Participants with skin diseases or treatments affecting skin barrier function, those undergoing dialysis, those routinely using moisturizers or topical agents on the assessment site, those who participated in another clinical study within the previous 4 months, or those judged unsuitable by the investigator.
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 03 Month 02 Day
Date of IRB - 2026 Year 03 Month 02 Day
Anticipated trial start date - 2026 Year 10 Month 01 Day
Last follow-up date - 2031 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071942
Disclaimer: Curated by HT Syndication.