Xerosis Cutis
Conditions
Keywords
xerosis cutis, geriatric, 12% ammonium lactate, 10% urea
Brief summary
This study aims to compare the efficacy and safety between moisturizing cream containing 12% ammonium lactate and 10% urea in geriatric with xerosis cutis. A double-blind randomized controlled trial with matching paired subject was conducted on 40 residents of a nursing home in Jakarta. Specified symptom sum score (SRRC), skin capacitance (SCap), transepidermal water loss (TEWL), and side effects were measured at baseline, week-2 and week-4 after therapy, and week-5 one week after therapy cessation. After a week of preconditioning, each subject received two different moisturizing creams to be applied on separate lower limbs.
Detailed description
Dry skin or xerosis cutis is widely known skin health issue in geriatric population with prevalence rate ranges between 29.5 - 85.5%. One of the internal etiological factors is decreased production of natural moisturizing factor as a humectant. Application of moisturizer is the mainstay treatment. Moisturizer with humectant property, like lactate and urea, could restore skin hydration and barrier dysfunction. This study aims to compare the efficacy and safety between moisturizing cream containing 12% ammonium lactate and 10% urea in geriatric with xerosis cutis.
Interventions
DRUGAmmonium Lactate
12% ammonium lactate moisturizing cream
DRUGUrea
10% urea moisturizing cream
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
same vehicle base ingredients, colour, smell, and packaging
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* presenting with clinical diagnosis of xerosis cutis or with using the specified symptom sum score (SRRC) * able to communicate well and perform daily activities independently * willing to follow the research and sign the informed consent
Exclusion criteria
* sensitive to the ingredients in the formulations * suffer from dermatitis or skin inflammation at the test site * erythema and fissure values based on SRRC value \>2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First Side Effect Evaluation | Performed at 2 weeks after therapy (day-15) | Subjective by the presence of contact dermatitis, folliculitis, and miliaria; objective by complaints of pruritus, sore, or stinging. |
| Second Side Effect Evaluation | Performed at day-29 (4 weeks after therapy) | Subjective by the presence of contact dermatitis, folliculitis, and miliaria; objective by complaints of pruritus, sore, or stinging. |
| Third Side Effect Evaluation | Performed at day-36 (5 weeks after therapy) | Subjective by the presence of contact dermatitis, folliculitis, and miliaria; objective by complaints of pruritus, sore, or stinging. Performed after 1 week of therapy discontinuation |
| First Evaluation of Specified Symptom Sum Score (SRRC) | initial visit (day 1) | System with grading of scaliness, roughness, redness, and cracks with score ranges from 0-12 because the redness and cracks scores were limited to 2. Performed before therapy. |
| Second Evaluation of Specified Symptom Sum Score (SRRC) | Change of SSRC at day 15 from initial visit | System with grading of scaliness, roughness, redness, and cracks with score ranges from 0-12 because the redness and cracks scores were limited to 2. Performed during therapy. |
| Third Evaluation of Specified Symptom Sum Score (SRRC) | Change of SSRC at day 29 from initial visit | System with grading of scaliness, roughness, redness, and cracks with score ranges from 0-12 because the redness and cracks scores were limited to 2. Performed during therapy. |
| Fourth Evaluation of Specified Symptom Sum Score (SRRC) | Change of SSRC at day 36 | System with grading of scaliness, roughness, redness, and cracks with score ranges from 0-12 because the redness and cracks scores were limited to 2. Performed after 1 week of therapy discontinuation |
| First Evaluation of Skin Capacitance (SCap) | Performed at initial visit (day-1) | Assess the skin barrier homeostasis condition using Corneometer® CM 825 (Courage - Khazaka, Germany). Performed before therapy. |
| Second Evaluation of Skin Capacitance (SCap) | Change of SCap at day-15 | Assess the skin barrier homeostasis condition using Corneometer® CM 825 (Courage - Khazaka, Germany). Performed during therapy. |
| Third Evaluation of Skin Capacitance (SCap) | Change of SCap at day-29 | Assess the skin barrier homeostasis condition using Corneometer® CM 825 (Courage - Khazaka, Germany). Performed during therapy. |
| Fourth Evaluation of Skin Capacitance (SCap) | Change of SCap at day-36 | Assess the skin barrier homeostasis condition using Corneometer® CM 825 (Courage - Khazaka, Germany). Performed after 1 week of therapy discontinuation |
| First Evaluation of Transepidermal Water Loss (TEWL) | Performed at initial visit (day-1) | Assess the skin barrier homeostasis condition using Tewameter® TM300 before therapy. |
| Second Evaluation of Transepidermal Water Loss (TEWL) | Change of TEWL at day-15 from initial visit | Assess the skin barrier homeostasis condition using Tewameter® TM300. Performed during therapy. |
| Third Evaluation of Transepidermal Water Loss (TEWL) | Change of TEWL at day-29 from initial visit | Assess the skin barrier homeostasis condition using Tewameter® TM300. Performed during therapy. |
| Fourth Evaluation of Transepidermal Water Loss (TEWL) | Change of TEWL at day-36 from initial visit | Assess the skin barrier homeostasis condition using Tewameter® TM300. Performed after 1 week of therapy discontinuation. |
Countries
Indonesia
Outcome results
None listed