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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2017-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effectiveness and Safety of Niacinamide 4% and Virgin Coconut Oil 30% for Secondary Prevention of Occupational Hand Dermatitis

NCT04218500

Contact Dermatitis of Hands

COMPLETED NA

Xerotic Dermatitis in Aged People

NCT01806935

Itching Symptoms Xerotic Dermatitis

COMPLETED NA

Utilizing Topical Sodium Hypochlorite to Ameliorate Radiation Dermatitis

NCT04630821

Radiation Dermatitis

TERMINATED NA

Enhancing SKIN Health and Safety in Aged CARE

NCT03824886

Xerosis Cutis Dry Skin Pruritus +5 more

COMPLETED NA

This Was a Clinical Study Investigating the Moisturization and Desquamation Effect of AmLactin® Rapid Relief Restoring Lotion + Ceramides on Dry Skin in Healthy Female Volunteers. AmLactin® Rapid Relief is an Over-the-counter Cosmetic

NCT04085809

Dry Skin

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Xerosis Cutis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

same vehicle base ingredients, colour, smell, and packaging

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

12% AMMONIUM LACTATE

Matching paired subject was conducted on 40 residents. Test subject received two different randomized moisturizing creams to be applied on two separate locations on the lower limbs twice a day for 4 weeks. One of the moisturising cream contained active ingredient 12% ammonium lactate. The evaluation of 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.

Group Type EXPERIMENTAL

Ammonium Lactate

Intervention Type DRUG

12% ammonium lactate moisturizing cream

10% UREA

Matching paired subject was conducted on 40 residents. Test subject received two different randomized moisturizing creams to be applied on two separate locations on the lower limbs twice a day for 4 weeks. One of the moisturising cream contained active ingredient 10% urea. The evaluation of 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.

Group Type ACTIVE_COMPARATOR

Urea

Intervention Type DRUG

10% urea moisturizing cream

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ammonium Lactate

12% ammonium lactate moisturizing cream

Intervention Type DRUG

Urea

10% urea moisturizing cream

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes