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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12% AMMONIUM LACTATE | Experimental | Matching paired subject was conducted on 40 residents. Test subject received two different randomized moisturizing creams to be applied on two separate locations on the lower limbs twice a day for 4 weeks. One of the moisturising cream contained active ingredient 12% ammonium lactate. The evaluation of 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. |
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| 10% UREA | Active Comparator | Matching paired subject was conducted on 40 residents. Test subject received two different randomized moisturizing creams to be applied on two separate locations on the lower limbs twice a day for 4 weeks. One of the moisturising cream contained active ingredient 10% urea. The evaluation of 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ammonium Lactate | Drug | 12% ammonium lactate moisturizing cream |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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 | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine University of Indonesia | Jakarta Pusat | DKI Jakarta | 10340 | Indonesia |
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| ID | Term |
|---|---|
| D019344 | Lactic Acid |
| D014508 | Urea |
| ID | Term |
|---|---|
| D007773 | Lactates |
| D006880 | Hydroxy Acids |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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same vehicle base ingredients, colour, smell, and packaging
| Urea |
| Drug |
10% urea moisturizing cream |
|
| 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. | 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 | Change of SCap at day-36 |
| First Evaluation of Transepidermal Water Loss (TEWL) | Assess the skin barrier homeostasis condition using Tewameter® TM300 before therapy. | 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. | 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. | 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. | 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. | 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. | 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 | Performed at day-36 (5 weeks after therapy) |
| D000577 |
| Amides |