Clinical trial NCT04127513: Comparison of 12% Ammonium Lactate and 10% Urea Cream in Geriatric With Xerosis Cutis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Xerosis Cutis
Keywords: xerosis cutis
geriatric
12% ammonium lactate
10% urea
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: First Evaluation of Specified Symptom Sum Score (SRRC)
timeFrame: initial visit (day 1)
measure: Second Evaluation of Specified Symptom Sum Score (SRRC)
timeFrame: Change of SSRC at day 15 from initial visit
measure: Third Evaluation of Specified Symptom Sum Score (SRRC)
timeFrame: Change of SSRC at day 29 from initial visit
measure: Fourth Evaluation of Specified Symptom Sum Score (SRRC)
timeFrame: Change of SSRC at day 36
measure: First Evaluation of Skin Capacitance (SCap)
timeFrame: Performed at initial visit (day-1)
measure: Second Evaluation of Skin Capacitance (SCap)
timeFrame: Change of SCap at day-15
measure: Third Evaluation of Skin Capacitance (SCap)
timeFrame: Change of SCap at day-29
measure: Fourth Evaluation of Skin Capacitance (SCap)
timeFrame: Change of SCap at day-36
measure: First Evaluation of Transepidermal Water Loss (TEWL)
timeFrame: Performed at initial visit (day-1)
measure: Second Evaluation of Transepidermal Water Loss (TEWL)
timeFrame: Change of TEWL at day-15 from initial visit
measure: Third Evaluation of Transepidermal Water Loss (TEWL)
timeFrame: Change of TEWL at day-29 from initial visit
measure: Fourth Evaluation of Transepidermal Water Loss (TEWL)
timeFrame: Change of TEWL at day-36 from initial visit
measure: First Side Effect Evaluation
timeFrame: Performed at 2 weeks after therapy (day-15)
measure: Second Side Effect Evaluation
timeFrame: Performed at day-29 (4 weeks after therapy)
measure: Third Side Effect Evaluation
timeFrame: Performed at day-36 (5 weeks after therapy)
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Faculty of Medicine University of Indonesia
state: DKI Jakarta
Study officials:
References: