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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
12% ammonium lactate moisturizing cream
10% urea moisturizing cream
Faculty of Medicine University of Indonesia
Jakarta Pusat, DKI Jakarta, Indonesia
First Evaluation of Specified Symptom Sum Score (SRRC)
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.
Time frame: initial visit (day 1)
Second Evaluation of Specified Symptom Sum Score (SRRC)
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.
Time frame: Change of SSRC at day 15 from initial visit
Third Evaluation of Specified Symptom Sum Score (SRRC)
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.
Time frame: Change of SSRC at day 29 from initial visit
Fourth Evaluation of Specified Symptom Sum Score (SRRC)
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
Time frame: Change of SSRC at day 36
First Evaluation of Skin Capacitance (SCap)
Assess the skin barrier homeostasis condition using Corneometer® CM 825 (Courage - Khazaka, Germany). Performed before therapy.
Time frame: Performed at initial visit (day-1)
Second Evaluation of Skin Capacitance (SCap)
Assess the skin barrier homeostasis condition using Corneometer® CM 825 (Courage - Khazaka, Germany). Performed during therapy.
Time frame: Change of SCap at day-15
Third Evaluation of Skin Capacitance (SCap)
Assess the skin barrier homeostasis condition using Corneometer® CM 825 (Courage - Khazaka, Germany). Performed during therapy.
Time frame: Change of SCap at day-29
Fourth Evaluation of Skin Capacitance (SCap)
Assess the skin barrier homeostasis condition using Corneometer® CM 825 (Courage - Khazaka, Germany). Performed after 1 week of therapy discontinuation
Time frame: Change of SCap at day-36
First Evaluation of Transepidermal Water Loss (TEWL)
Assess the skin barrier homeostasis condition using Tewameter® TM300 before therapy.
Time frame: Performed at initial visit (day-1)
Second Evaluation of Transepidermal Water Loss (TEWL)
Assess the skin barrier homeostasis condition using Tewameter® TM300. Performed during therapy.
Time frame: Change of TEWL at day-15 from initial visit
Third Evaluation of Transepidermal Water Loss (TEWL)
Assess the skin barrier homeostasis condition using Tewameter® TM300. Performed during therapy.
Time frame: Change of TEWL at day-29 from initial visit
Fourth Evaluation of Transepidermal Water Loss (TEWL)
Assess the skin barrier homeostasis condition using Tewameter® TM300. Performed after 1 week of therapy discontinuation.
Time frame: Change of TEWL at day-36 from initial visit
First Side Effect Evaluation
Subjective by the presence of contact dermatitis, folliculitis, and miliaria; objective by complaints of pruritus, sore, or stinging.
Time frame: Performed at 2 weeks after therapy (day-15)
Second Side Effect Evaluation
Subjective by the presence of contact dermatitis, folliculitis, and miliaria; objective by complaints of pruritus, sore, or stinging.
Time frame: Performed at day-29 (4 weeks after therapy)
Third Side Effect Evaluation
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
Time frame: Performed at day-36 (5 weeks after therapy)
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