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

Xerosis Cutis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04127513
• Other study ID #: ThesisEyleny
• Status: Completed
• Phase: Phase 3
• Start date: April 1, 2017
• Est. completion date: May 31, 2017

Study information

• Verified date: October 2019
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Xerosis Cutis

Intervention

Drug:
• Ammonium Lactate
12% ammonium lactate moisturizing cream
• Urea
10% urea moisturizing cream

Locations

Country	Name	City	State
Indonesia	Faculty of Medicine University of Indonesia	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	First Evaluation of Transepidermal Water Loss (TEWL)	Assess the skin barrier homeostasis condition using Tewameter® TM300 before therapy.	Performed at initial visit (day-1)
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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)
Primary	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)