This study investigated the efficacy and safety of a moisturizer containing 5% hydro-urea, ceramide, and MVE technology compared with petrolatum for dry skin in the elderly.
This study was a double-blind, randomized controlled trial was conducted on 48 elderly population of a nursing home in Jakarta. The participants, aged 60 years and older, had been diagnosed with dry skin. Each subject was randomly assigned to receive one of two moisturizers (either a formulation containing 5% hydro-urea and ceramides with MVE technology, or petrolatum) for topical application to both lower legs. 5-D pruritus scale, dermatology life quality index (DLQI), specified symptom sum score (SRRC), transepidermal water loss (TEWL), and skin capacitance (SCap) were measured at day 0, 7, 28, and three days post-treatment cessation (day 31).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
Moisturizer Containing a Combination of 5% Hydro-Urea, Ceramide, with MultiVesicular Emulsion Technology
Vaseline album
Universitas Indonesia, Jakarta Pusat, Jakarta 10430
Jakarta Pusat, Jakarta Special Capital Region, Indonesia
Change in SRRC
Specified symptom sum score. Measuring dry skin using four variables (scale, roughness, redness, and cracking) in score ranged from 1 to 4 for each variable. The highest the value marks the driest skin
Time frame: Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation).
Change in Skin Capacitance
SCap measured in (AU)
Time frame: Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation).
Change in TEWL
Transepidermal water loss reflects the amount of water lost through evaporation
Time frame: Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation).
Change in 5-D Pruritus Scale
This multidimensional questionnaire is used to measure itch intensity. The 5-D scale evaluates five domains of itch: duration, degree, direction, disability, and distribution. The total scores range from 5 to 25.
Time frame: Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation).
Change in Dermatology Life Quality Index
The Dermatology Life Quality Index (DLQI) questionnaire is used to measure the impact of xerosis cutis on the subject's quality of life. The questionnaire evaluates symptoms, daily activities, leisure, work, personal relationships, and treatments. The total scores range from 0 to 30
Time frame: Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation).
Adverse Events
Assessment of safety and tolerability by evaluating the occurrence of subjective side effects (including itching, discomfort, and stinging) and objective side effects (including contact dermatitis and folliculitis) following the application of the moisturizers.
Time frame: Assessed throughout the 31-day observation period
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