Xerosis CutisPhase 3NCT04127513
Comparison of 12% Ammonium Lactate and 10% Urea Cream in Geriatric With Xerosis Cutis
A Phase 3 study testing Ammonium Lactate and Urea in people with Xerosis Cutis, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Xerosis Cutis
- What is being tested?
- Ammonium Lactate and Urea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Apr 2017to 31 May 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Faculty of Medicine University of Indonesia
Jakarta Pusat, DKI Jakarta, 10340
About this study
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
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.
Read the 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.
- Conditions
- Xerosis Cutis
- Being tested
- Ammonium Lactate, Urea
- Keywords
- xerosis cutis, geriatric, 12% ammonium lactate, 10% urea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ammonium LactateDrug
12% ammonium lactate moisturizing cream
UreaDrug
10% urea moisturizing cream
| Study group | Role | What they receive |
|---|---|---|
| 12% AMMONIUM LACTATE | Experimental | 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. Receives: Drug: Ammonium Lactate |
| 10% UREA | Active comparator | 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. Receives: Drug: Urea |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Evaluation of Specified Symptom Sum Score (SRRC)
System with grading of scaliness, roughness, redness, and cracks with score ranges from 0-12 because the redness and cracks scores were limited to 2. Performed before therapy.
Measured: initial visit (day 1)
Second Evaluation of Specified Symptom Sum Score (SRRC)
System with grading of scaliness, roughness, redness, and cracks with score ranges from 0-12 because the redness and cracks scores were limited to 2. Performed during therapy.
Measured: Change of SSRC at day 15 from initial visit
Third Evaluation of Specified Symptom Sum Score (SRRC)
System with grading of scaliness, roughness, redness, and cracks with score ranges from 0-12 because the redness and cracks scores were limited to 2. Performed during therapy.
Measured: Change of SSRC at day 29 from initial visit
Fourth Evaluation of Specified Symptom Sum Score (SRRC)
System with grading of scaliness, roughness, redness, and cracks with score ranges from 0-12 because the redness and cracks scores were limited to 2. Performed after 1 week of therapy discontinuation
Measured: Change of SSRC at day 36
First Evaluation of Skin Capacitance (SCap)
Assess the skin barrier homeostasis condition using Corneometer® CM 825 (Courage - Khazaka, Germany). Performed before therapy.
Measured: Performed at initial visit (day-1)
Second Evaluation of Skin Capacitance (SCap)
Assess the skin barrier homeostasis condition using Corneometer® CM 825 (Courage - Khazaka, Germany). Performed during therapy.
Measured: Change of SCap at day-15
Third Evaluation of Skin Capacitance (SCap)
Assess the skin barrier homeostasis condition using Corneometer® CM 825 (Courage - Khazaka, Germany). Performed during therapy.
Measured: Change of SCap at day-29
Fourth Evaluation of Skin Capacitance (SCap)
Assess the skin barrier homeostasis condition using Corneometer® CM 825 (Courage - Khazaka, Germany). Performed after 1 week of therapy discontinuation
Measured: Change of SCap at day-36
First Evaluation of Transepidermal Water Loss (TEWL)
Assess the skin barrier homeostasis condition using Tewameter® TM300 before therapy.
Measured: Performed at initial visit (day-1)
Second Evaluation of Transepidermal Water Loss (TEWL)
Assess the skin barrier homeostasis condition using Tewameter® TM300. Performed during therapy.
Measured: Change of TEWL at day-15 from initial visit
Third Evaluation of Transepidermal Water Loss (TEWL)
Assess the skin barrier homeostasis condition using Tewameter® TM300. Performed during therapy.
Measured: Change of TEWL at day-29 from initial visit
Fourth Evaluation of Transepidermal Water Loss (TEWL)
Assess the skin barrier homeostasis condition using Tewameter® TM300. Performed after 1 week of therapy discontinuation.
Measured: Change of TEWL at day-36 from initial visit
First Side Effect Evaluation
Subjective by the presence of contact dermatitis, folliculitis, and miliaria; objective by complaints of pruritus, sore, or stinging.
Measured: Performed at 2 weeks after therapy (day-15)
Second Side Effect Evaluation
Subjective by the presence of contact dermatitis, folliculitis, and miliaria; objective by complaints of pruritus, sore, or stinging.
Measured: Performed at day-29 (4 weeks after therapy)
Third Side Effect Evaluation
Subjective by the presence of contact dermatitis, folliculitis, and miliaria; objective by complaints of pruritus, sore, or stinging. Performed after 1 week of therapy discontinuation
Measured: Performed at day-36 (5 weeks after therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start1 Apr 2017
- Primary completion31 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Xerosis CutisStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eyleny Meisyah Fitri, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127513
- Sponsor's protocol ID
- ThesisEyleny
- Status last verified
- Oct 2019
- First submitted
- 10 Oct 2019
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04127513
- Acronym / sponsor ID
- ThesisEyleny
- Conditions
- Xerosis Cutis
- Keywords
- xerosis cutis, geriatric, 12% ammonium lactate, 10% urea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12% AMMONIUM LACTATE | Experimental | Drug: Ammonium LactateMatching 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. |
| 10% UREA | Active comparator | Drug: UreaMatching 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ammonium Lactate12% ammonium lactate moisturizing cream | Drug | 12% AMMONIUM LACTATE |
| Urea10% urea moisturizing cream | Drug | 10% UREA |
Primary outcome
First Evaluation of Specified Symptom Sum Score (SRRC)
Time frame: initial visit (day 1)
System with grading of scaliness, roughness, redness, and cracks with score ranges from 0-12 because the redness and cracks scores were limited to 2. Performed before therapy.
Second Evaluation of Specified Symptom Sum Score (SRRC)
Time frame: Change of SSRC at day 15 from initial visit
System with grading of scaliness, roughness, redness, and cracks with score ranges from 0-12 because the redness and cracks scores were limited to 2. Performed during therapy.
Third Evaluation of Specified Symptom Sum Score (SRRC)
Time frame: Change of SSRC at day 29 from initial visit
System with grading of scaliness, roughness, redness, and cracks with score ranges from 0-12 because the redness and cracks scores were limited to 2. Performed during therapy.
Fourth Evaluation of Specified Symptom Sum Score (SRRC)
Time frame: Change of SSRC at day 36
System with grading of scaliness, roughness, redness, and cracks with score ranges from 0-12 because the redness and cracks scores were limited to 2. Performed after 1 week of therapy discontinuation
First Evaluation of Skin Capacitance (SCap)
Time frame: Performed at initial visit (day-1)
Assess the skin barrier homeostasis condition using Corneometer® CM 825 (Courage - Khazaka, Germany). Performed before therapy.
Second Evaluation of Skin Capacitance (SCap)
Time frame: Change of SCap at day-15
Assess the skin barrier homeostasis condition using Corneometer® CM 825 (Courage - Khazaka, Germany). Performed during therapy.
Third Evaluation of Skin Capacitance (SCap)
Time frame: Change of SCap at day-29
Assess the skin barrier homeostasis condition using Corneometer® CM 825 (Courage - Khazaka, Germany). Performed during therapy.
Fourth Evaluation of Skin Capacitance (SCap)
Time frame: Change of SCap at day-36
Assess the skin barrier homeostasis condition using Corneometer® CM 825 (Courage - Khazaka, Germany). Performed after 1 week of therapy discontinuation
First Evaluation of Transepidermal Water Loss (TEWL)
Time frame: Performed at initial visit (day-1)
Assess the skin barrier homeostasis condition using Tewameter® TM300 before therapy.
Second Evaluation of Transepidermal Water Loss (TEWL)
Time frame: Change of TEWL at day-15 from initial visit
Assess the skin barrier homeostasis condition using Tewameter® TM300. Performed during therapy.
Third Evaluation of Transepidermal Water Loss (TEWL)
Time frame: Change of TEWL at day-29 from initial visit
Assess the skin barrier homeostasis condition using Tewameter® TM300. Performed during therapy.
Fourth Evaluation of Transepidermal Water Loss (TEWL)
Time frame: Change of TEWL at day-36 from initial visit
Assess the skin barrier homeostasis condition using Tewameter® TM300. Performed after 1 week of therapy discontinuation.
First Side Effect Evaluation
Time frame: Performed at 2 weeks after therapy (day-15)
Subjective by the presence of contact dermatitis, folliculitis, and miliaria; objective by complaints of pruritus, sore, or stinging.
Second Side Effect Evaluation
Time frame: Performed at day-29 (4 weeks after therapy)
Subjective by the presence of contact dermatitis, folliculitis, and miliaria; objective by complaints of pruritus, sore, or stinging.
Third Side Effect Evaluation
Time frame: Performed at day-36 (5 weeks after therapy)
Subjective by the presence of contact dermatitis, folliculitis, and miliaria; objective by complaints of pruritus, sore, or stinging. Performed after 1 week of therapy discontinuation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ammonium Lactate and Urea in people with Xerosis Cutis, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First Evaluation of Specified Symptom Sum Score (SRRC) (time frame: initial visit (day 1)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.