CompletedPhase 3

Comparison of Efficacy and Safety Profile Between Moisturizers Containing a Combination of 5% Hydro-Urea, Ceramide, With MultiVesicular Emulsion Technology and Petrolatum on Dry Skin in the Elderly

Indonesia48 participantsStarted 2025-11-10

Plain-language summary

This study investigated the efficacy and safety of a moisturizer containing 5% hydro-urea, ceramide, and MVE technology compared with petrolatum for dry skin in the elderly.

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: * individuals aged 60 years or older who have been diagnosed with clinically dry skin (indicated by SRRC score ranging from 5 to 16), have not used topical moisturizers for at least 2 weeks and oral moisturizing supplements for at least 4 weeks prior, willingness to comply with the research procedures, able to communicate well, and provide written consent by signing the informed consent from. Exclusion Criteria: * individuals with a previous record of hypersensitivity to the moisturizer, dermatitis, or other skin disease affecting the lower extremities, and those with an erythema/fissure score greater than 2 based on SRRC.

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

Change in SRRC

Timeframe: Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation).

Change in Skin Capacitance

Timeframe: Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation).

Change in TEWL

Timeframe: Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation).

Change in 5-D Pruritus Scale

Timeframe: Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation).

Change in Dermatology Life Quality Index

Timeframe: Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation).

Adverse Events

Timeframe: Assessed throughout the 31-day observation period

Trial details

NCT IDNCT07739355

SponsorDr. dr. Lili Legiawati, SpKK(K)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-11

View on ClinicalTrials.gov More Dry Skin in the Elderly trials

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.

What they're measuring

Change in SRRC

Timeframe: Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation).

Change in Skin Capacitance

Timeframe: Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation).

Change in TEWL

Timeframe: Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation).

Change in 5-D Pruritus Scale

Timeframe: Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation).

Change in Dermatology Life Quality Index

Timeframe: Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation).

Adverse Events

Timeframe: Assessed throughout the 31-day observation period