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 range60 Years

SexALL

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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

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

Fourth Evaluation of Skin Capacitance (SCap)

Timeframe: Change of SCap at day-36

Trial details

NCT IDNCT04127513

SponsorIndonesia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-05-31

View on ClinicalTrials.gov More Xerosis Cutis trials