CompletedPhase 3

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

Indonesia40 participantsStarted 2017-04-01

Plain-language 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.

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

First Evaluation of Specified Symptom Sum Score (SRRC)

Timeframe: initial visit (day 1)

Second Evaluation of Specified Symptom Sum Score (SRRC)

Timeframe: Change of SSRC at day 15 from initial visit

Third Evaluation of Specified Symptom Sum Score (SRRC)

Timeframe: Change of SSRC at day 29 from initial visit

Fourth Evaluation of Specified Symptom Sum Score (SRRC)

Timeframe: Change of SSRC at day 36

First Evaluation of Skin Capacitance (SCap)

Timeframe: Performed at initial visit (day-1)

Second Evaluation of Skin Capacitance (SCap)

Timeframe: Change of SCap at day-15

Third Evaluation of Skin Capacitance (SCap)

Timeframe: Change of SCap at day-29

Trial details

NCT IDNCT04127513

SponsorIndonesia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-05-31

View on ClinicalTrials.gov More Xerosis Cutis trials