Comparison of 12% Ammonium Lactate and 10% Urea Cream in Geriatric With Xerosis Cutis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Efficacy and Safety Between Moisturising Cream Containing 12% Ammonium Lactate AND 10% Urea in Geriatric With Xerosis Cutis: Double Blind Randomised Controlled Trial

Conditions
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Xerosis Cutis

Intervention / Treatment
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* Drug: Ammonium Lactate
* Drug: Urea


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 12% AMMONIUM LACTATE<br>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. | Drug: Ammonium Lactate<br>* 12% ammonium lactate moisturizing cream<br>|
| Active Comparator: 10% UREA<br>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. | Drug: Urea<br>* 10% urea moisturizing cream<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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xerosis cutis, geriatric, 12% ammonium lactate, 10% urea