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

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

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.

Study Overview

• Status: Completed
• Conditions: Xerosis Cutis
• Intervention / Treatment: Drug: Ammonium Lactate; Drug: Urea

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10340
      • Faculty of Medicine University of Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 12% AMMONIUM LACTATE; 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; 12% ammonium lactate moisturizing cream
Active Comparator: 10% UREA; 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; 10% urea moisturizing cream

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): May 31, 2017
• Study Completion (Actual): May 31, 2017

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (Actual): October 15, 2019

Study Record Updates

• Last Update Posted (Actual): October 15, 2019
• Last Update Submitted That Met QC Criteria: October 14, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: geriatric; xerosis cutis; 12% ammonium lactate; 10% urea
• Other Study ID Numbers: ThesisEyleny

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No