Xerosis in Type 2 Diabetes Mellitus Moisturizer, Pseudoceratmide, Xerosis, Type 2 Diabetes Mellitus
Conditions
Interventions
Participants will apply 2 fingertip units of the pseudoceramide containing moisturizing cream to the randomized intervention lower leg twice daily (morning and evening) within 5 minutes after bathing
Experimental Other,Active Comparator Other
Pseudoceramide Containing Intensive Moisture Care Moisture Cream,Routine Moisturizer
Sponsors
Kao Consumer Products (Southeast Asia), Co., Ltd
Eligibility
Sex/Gender
All
Age
21 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Thai patients, both male and female, aged 21-65 years old. 2. Documented diagnosis of type 2 diabetes mellitus for at least 3 months, confirmed by laboratory results. 3. Currently managed with lifestyle modification and/or oral anti-diabetic agents. 4. Presence of grade 3 xerosis on both lower legs based on the Overall Dryness Scale 5. History of regular use of a moisturizer on both lower legs for at least 4 weeks prior to study enrollment. Participants must be able to continue using the same moisturizer on the control side during the study period, following standardized instructions regarding amount and frequency of application. 6. Ability to comprehend study procedures and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Presence of chronic dermatologic diseases on the study area, such as atopic dermatitis, psoriasis, or contact dermatitis. 2. Evidence of acute inflammatory skin conditions on the lower legs, including pustules or edema. (Erythema without inflammation associated with xerosis will not be excluded.) 3. Current treatment of diabetes mellitus with insulin injections. 4. Current or recent use (within the past 4 weeks) of topical corticosteroids, immunomodulators, or any topical medications on the lower legs unrelated to diabetes care. 5. Ongoing use of ceramide-containing skincare or nourishing products on the lower legs. 6. Ongoing use of other moisturizing agents on the lower legs containing active ingredients known to affect skin hydration or barrier function, such as hyaluronic acid, niacinamide (vitamin B3), panthenol (vitamin B5), or retinoids (vitamin A derivatives).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stratum Corneum Hydration (SCH) Baseline (Day 0), Week 2 (Day 14), and Week 4 (Day 28) Corneometer | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Skin Condition (Dryness, Scaling, Fissuring, Erythema) Baseline (Day 0), Week 2 (Day 14), and Week 4 (Day 28) Physician's Clinical Rating Scales,Patient-Reported Symptoms (Dryness, Pruritus, Scaling) Baseline (Day 0), Week 2 (Day 14), and Week 4 (Day 28) Numeric Rating Scales (NRS),Patient Satisfaction Week 2 (Day 14), and Week 4 (Day 28) Structured Questionnaires,Safety (Adverse Events) Throughout the study period Adverse Event Monitoring | — |
Countries
Thailand
Contacts
Public ContactTHAMTHIWAT NARARATWANCHAI
Department of Dermatology, School of Anti-Aging and Regenerative Medicine, Mae Fah Luang University, Bangkok, Thailand.
Outcome results
None listed