Dry Skin in the Elderly
Conditions
Keywords
ceramides, dry skin, elderly, multivesicular emulsion technology, urea
Brief summary
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.
Detailed description
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).
Interventions
DRUGMoisturizer Containing a Combination of 5% Hydro-Urea, Ceramide, with MultiVesicular Emulsion Technology
Moisturizer Containing a Combination of 5% Hydro-Urea, Ceramide, with MultiVesicular Emulsion Technology
Vaseline album
Sponsors
Dr. dr. Lili Legiawati, SpKK(K)
L'Oreal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* individuals aged 60 years or older who have been diagnosed with clinically dry skin (indicated by SRRC score ranging from 5 to 16), have not used topical moisturizers for at least 2 weeks and oral moisturizing supplements for at least 4 weeks prior, willingness to comply with the research procedures, able to communicate well, and provide written consent by signing the informed consent from.
Exclusion criteria
* individuals with a previous record of hypersensitivity to the moisturizer, dermatitis, or other skin disease affecting the lower extremities, and those with an erythema/fissure score greater than 2 based on SRRC.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in SRRC | Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation). | 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 |
| Change in Skin Capacitance | Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation). | SCap measured in (AU) |
| Change in TEWL | Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation). | Transepidermal water loss reflects the amount of water lost through evaporation |
| Change in 5-D Pruritus Scale | Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation). | 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. |
| Change in Dermatology Life Quality Index | Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation). | 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 |
| Adverse Events | Assessed throughout the 31-day observation period | 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. |
Countries
Indonesia
Outcome results
None listed