Dry Skin in the ElderlyPhase 3NCT07739355
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
A Phase 3 study testing Moisturizer Containing a Combination of 5% Hydro-Urea, Ceramide, with MultiVesicular Emulsion Technology and Petrolatum Ointment in people with Dry Skin in the Elderly, run by Dr. dr. Lili Legiawati, SpKK(K) at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dry Skin in the Elderly
- What is being tested?
- Moisturizer Containing a Combination of 5% Hydro-Urea, Ceramide, with MultiVesicular Emulsion Technology and Petrolatum Ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteIndonesia
- Study dates
- 10 Nov 2025to 11 Dec 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Universitas Indonesia, Jakarta Pusat, Jakarta 10430
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
Official title: 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: A Randomized, Controlled, Double-Blind Clinical Trial
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.
Read the detailed description
This study was a double-blind, randomized controlled trial was conducted on 48 elderly population of a nursing home in Jakarta. The participants, aged 60 years and older, had been diagnosed with dry skin. Each subject was randomly assigned to receive one of two moisturizers (either a formulation containing 5% hydro-urea and ceramides with MVE technology, or petrolatum) for topical application to both lower legs. 5-D pruritus scale, dermatology life quality index (DLQI), specified symptom sum score (SRRC), transepidermal water loss (TEWL), and skin capacitance (SCap) were measured at day 0, 7, 28, and three days post-treatment cessation (day 31).
- Conditions
- Dry Skin in the Elderly
- Being tested
- Moisturizer Containing a Combination of 5% Hydro-Urea, Ceramide, with MultiVesicular Emulsion Technology, Petrolatum Ointment
- Keywords
- ceramides, dry skin, elderly, multivesicular emulsion technology, urea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moisturizer Containing a Combination of 5% Hydro-Urea, Ceramide, with MultiVesicular Emulsion TechnologyDrug
Moisturizer Containing a Combination of 5% Hydro-Urea, Ceramide, with MultiVesicular Emulsion Technology
Petrolatum OintmentDrug
Vaseline album
| Study group | Role | What they receive |
|---|---|---|
| Moisturizer containing a combination of 5% hydro-urea, ceramides, with MVE technology | Experimental | Moisturizer containing a combination of 5% hydro-urea, ceramides, with MVE technology twice a day Receives: Drug: Moisturizer Containing a Combination of 5% Hydro-Urea, Ceramide, with MultiVesicular Emulsion Technology |
| Petrolatum | Active comparator | Petrolatum twice a day Receives: Drug: Petrolatum Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SRRC
Specified symptom sum score. Measuring dry skin using four variables (scale, roughness, redness, and cracking) in score ranged from 1 to 4 for each variable. The highest the value marks the driest skin
Measured: Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation).
Change in Skin Capacitance
SCap measured in (AU)
Measured: Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation).
Change in TEWL
Transepidermal water loss reflects the amount of water lost through evaporation
Measured: Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation).
Change in 5-D Pruritus Scale
This multidimensional questionnaire is used to measure itch intensity. The 5-D scale evaluates five domains of itch: duration, degree, direction, disability, and distribution. The total scores range from 5 to 25.
Measured: Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation).
Change in Dermatology Life Quality Index
The Dermatology Life Quality Index (DLQI) questionnaire is used to measure the impact of xerosis cutis on the subject's quality of life. The questionnaire evaluates symptoms, daily activities, leisure, work, personal relationships, and treatments. The total scores range from 0 to 30
Measured: Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation).
Adverse Events
Assessment of safety and tolerability by evaluating the occurrence of subjective side effects (including itching, discomfort, and stinging) and objective side effects (including contact dermatitis and folliculitis) following the application of the moisturizers.
Measured: Assessed throughout the 31-day observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start10 Nov 2025
- Primary completion11 Dec 2025
- Study completion11 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Dry Skin in the ElderlyStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. dr. Lili Legiawati, SpKK(K)
- Sponsor type
- University, hospital or other
- Collaborators
- L'Oreal
- Responsible party
- Sponsor-investigator, Dr. dr. Lili Legiawati, SpKK(K), Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739355
- Sponsor's protocol ID
- KET-1521UN2.F1ETIKPPM00022025
- Other IDs
- KET-1521UN2.F1ETIKPPM00022025
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Danby SG, Andrew PV, Brown K, Chittock J, Kay LJ, Cork MJ. An Investigation of the Skin Barrier Restoring Effects of a Cream and Lotion Containing Ceramides in a Multi-vesicular Emulsion in People with Dry, Eczema-Prone, Skin: The RESTORE Study Phase 1. Dermatol Ther (Heidelb). 2020 Oct;10(5):1031-1041. doi: 10.1007/s13555-020-00426-3. Epub 2020 Jul 15.
PubMed 32671664Spada F, Barnes TM, Greive KA. Skin hydration is significantly increased by a cream formulated to mimic the skin's own natural moisturizing systems. Clin Cosmet Investig Dermatol. 2018 Oct 15;11:491-497. doi: 10.2147/CCID.S177697. eCollection 2018.
PubMed 30410378Loden M. The clinical benefit of moisturizers. J Eur Acad Dermatol Venereol. 2005 Nov;19(6):672-88; quiz 686-7. doi: 10.1111/j.1468-3083.2005.01326.x.
PubMed 16268870Yahya YF, Roiana N, Andarina R, Suprapti, Saleh I. Efficacy of 20% urea cream on uremic pruritus with uremic xerosis in chronic renal failure patients undergoing hemodialysis. Berkala Ilmu Kesehatan Kulit dan Kelamin; 2018. 30 (1), 1-9. https://doi.org/10.20473/bikk.V30.1.2018.1-9.
Di Nardo A, Wertz P, Giannetti A, Seidenari S. Ceramide and cholesterol composition of the skin of patients with atopic dermatitis. Acta Derm Venereol. 1998 Jan;78(1):27-30. doi: 10.1080/00015559850135788.
PubMed 9498022Pan M, Heinecke G, Bernardo S, Tsui C, Levitt J. Urea: a comprehensive review of the clinical literature. Dermatol Online J. 2013 Nov 15;19(11):20392.
PubMed 24314769Draelos ZD, Baalbaki NH, Raab S, Colon G. The Effect of a Ceramide-Containing Product on Stratum Corneum Lipid Levels in Dry Legs. J Drugs Dermatol. 2020 Apr 1;19(4):372-376. doi: 10.36849/JDD.2020.4796.
PubMed 32272513Badan Pusat Statistik. Statistik Indonesia 2025: Statistical Yearbook of Indonesia 2025. Vol 53. Jakarta: Badan Pusat Statistik; 2025.
Moniaga CS, Tominaga M, Takamori K. Mechanisms and Management of Itch in Dry Skin. Acta Derm Venereol. 2020 Jan 15;100(2):adv00024. doi: 10.2340/00015555-3344.
PubMed 31940044Legiawati L, Bramono K, Indriatmi W, Yunir E, Setiati S, Jusman SWA, Purwaningsih EH, Wibowo H, Danarti R. Oral and Topical Centella asiatica in Type 2 Diabetes Mellitus Patients with Dry Skin: A Three-Arm Prospective Randomized Double-Blind Controlled Trial. Evid Based Complement Alternat Med. 2020 Aug 26;2020:7253560. doi: 10.1155/2020/7253560. eCollection 2020.
PubMed 32908567Stettler H, Crowther JM, Brandt M, Boxshall A, Lu B, de Salvo R, Laing S, Hennighausen N, Bielfeldt S, Blenkiron P. Multi parametric biophysical assessment of treatment effects on xerotic skin. Skin Health Dis. 2021 Mar 21;1(2):e21. doi: 10.1002/ski2.21. eCollection 2021 Jun.
PubMed 35664981Serup J. EEMCO guidance for the assessment of dry skin (xerosis) and ichthyosis: clinical scoring systems. Skin Res Technol. 1995 Aug;1(3):109-14. doi: 10.1111/j.1600-0846.1995.tb00029.x.
PubMed 27328437Norman RA. Xerosis and pruritus in the elderly: recognition and management. Dermatol Ther. 2003;16(3):254-9. doi: 10.1046/j.1529-8019.2003.01635.x.
PubMed 14510882Widaty S, Soebono H, Nilasari H, Listiawan MY, Siswati AS, Triwahyudi D, et al. Panduan Praktik Klinis Bagi Dokter Spesialis Kulit dan Kelamin di Indonesia. Jakarta: PERDOSKI; 2017. h. 289-91.
Paul C, Maumus-Robert S, Mazereeuw-Hautier J, Guyen CN, Saudez X, Schmitt AM. Prevalence and risk factors for xerosis in the elderly: a cross-sectional epidemiological study in primary care. Dermatology. 2011;223(3):260-5. doi: 10.1159/000334631. Epub 2011 Nov 22.
PubMed 22104182
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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: A Randomized, Controlled, Double-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT07739355
- Acronym / sponsor ID
- KET-1521UN2.F1ETIKPPM00022025
- Conditions
- Dry Skin in the Elderly
- Keywords
- ceramides, dry skin, elderly, multivesicular emulsion technology, urea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Dr. dr. Lili Legiawati, SpKK(K)University, hospital or other
- Collaborators
- L'Oreal
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 11 Dec 2025 (actual)
- Study completion
- 11 Dec 2025 (actual)
- First posted
- 31 Jul 2026 (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 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.
Detailed description
This study was a double-blind, randomized controlled trial was conducted on 48 elderly population of a nursing home in Jakarta. The participants, aged 60 years and older, had been diagnosed with dry skin. Each subject was randomly assigned to receive one of two moisturizers (either a formulation containing 5% hydro-urea and ceramides with MVE technology, or petrolatum) for topical application to both lower legs. 5-D pruritus scale, dermatology life quality index (DLQI), specified symptom sum score (SRRC), transepidermal water loss (TEWL), and skin capacitance (SCap) were measured at day 0, 7, 28, and three days post-treatment cessation (day 31).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moisturizer containing a combination of 5% hydro-urea, ceramides, with MVE technology | Experimental | Drug: Moisturizer Containing a Combination of 5% Hydro-Urea, Ceramide, with MultiVesicular Emulsion TechnologyMoisturizer containing a combination of 5% hydro-urea, ceramides, with MVE technology twice a day |
| Petrolatum | Active comparator | Drug: Petrolatum OintmentPetrolatum twice a day |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Moisturizer Containing a Combination of 5% Hydro-Urea, Ceramide, with MultiVesicular Emulsion TechnologyMoisturizer Containing a Combination of 5% Hydro-Urea, Ceramide, with MultiVesicular Emulsion Technology | Drug | Moisturizer containing a combination of 5% hydro-urea, ceramides, with MVE technology |
| Petrolatum OintmentVaseline album | Drug | Petrolatum |
Primary outcome
Change in SRRC
Time frame: Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation).
Specified symptom sum score. Measuring dry skin using four variables (scale, roughness, redness, and cracking) in score ranged from 1 to 4 for each variable. The highest the value marks the driest skin
Change in Skin Capacitance
Time frame: Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation).
SCap measured in (AU)
Change in TEWL
Time frame: Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation).
Transepidermal water loss reflects the amount of water lost through evaporation
Change in 5-D Pruritus Scale
Time frame: Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation).
This multidimensional questionnaire is used to measure itch intensity. The 5-D scale evaluates five domains of itch: duration, degree, direction, disability, and distribution. The total scores range from 5 to 25.
Change in Dermatology Life Quality Index
Time frame: Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation).
The Dermatology Life Quality Index (DLQI) questionnaire is used to measure the impact of xerosis cutis on the subject's quality of life. The questionnaire evaluates symptoms, daily activities, leisure, work, personal relationships, and treatments. The total scores range from 0 to 30
Adverse Events
Time frame: Assessed throughout the 31-day observation period
Assessment of safety and tolerability by evaluating the occurrence of subjective side effects (including itching, discomfort, and stinging) and objective side effects (including contact dermatitis and folliculitis) following the application of the moisturizers.
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 31 Jul 2026.
- Background: PubMed 32671664Danby SG, Andrew PV, Brown K, Chittock J, Kay LJ, Cork MJ. An Investigation of the Skin Barrier Restoring Effects of a Cream and Lotion Containing Ceramides in a Multi-vesicular Emulsion in People with Dry, Eczema-Prone, Skin: The RESTORE Study Phase 1. Dermatol Ther (Heidelb). 2020 Oct;10(5):1031-1041. doi: 10.1007/s13555-020-00426-3. Epub 2020 Jul 15.
- Background: PubMed 30410378Spada F, Barnes TM, Greive KA. Skin hydration is significantly increased by a cream formulated to mimic the skin's own natural moisturizing systems. Clin Cosmet Investig Dermatol. 2018 Oct 15;11:491-497. doi: 10.2147/CCID.S177697. eCollection 2018.
- Background: PubMed 16268870Loden M. The clinical benefit of moisturizers. J Eur Acad Dermatol Venereol. 2005 Nov;19(6):672-88; quiz 686-7. doi: 10.1111/j.1468-3083.2005.01326.x.
- BackgroundYahya YF, Roiana N, Andarina R, Suprapti, Saleh I. Efficacy of 20% urea cream on uremic pruritus with uremic xerosis in chronic renal failure patients undergoing hemodialysis. Berkala Ilmu Kesehatan Kulit dan Kelamin; 2018. 30 (1), 1-9. https://doi.org/10.20473/bikk.V30.1.2018.1-9.
- Background: PubMed 9498022Di Nardo A, Wertz P, Giannetti A, Seidenari S. Ceramide and cholesterol composition of the skin of patients with atopic dermatitis. Acta Derm Venereol. 1998 Jan;78(1):27-30. doi: 10.1080/00015559850135788.
- Background: PubMed 24314769Pan M, Heinecke G, Bernardo S, Tsui C, Levitt J. Urea: a comprehensive review of the clinical literature. Dermatol Online J. 2013 Nov 15;19(11):20392.
- Background: PubMed 32272513Draelos ZD, Baalbaki NH, Raab S, Colon G. The Effect of a Ceramide-Containing Product on Stratum Corneum Lipid Levels in Dry Legs. J Drugs Dermatol. 2020 Apr 1;19(4):372-376. doi: 10.36849/JDD.2020.4796.
- BackgroundBadan Pusat Statistik. Statistik Indonesia 2025: Statistical Yearbook of Indonesia 2025. Vol 53. Jakarta: Badan Pusat Statistik; 2025.
- Background: PubMed 31940044Moniaga CS, Tominaga M, Takamori K. Mechanisms and Management of Itch in Dry Skin. Acta Derm Venereol. 2020 Jan 15;100(2):adv00024. doi: 10.2340/00015555-3344.
- Background: PubMed 32908567Legiawati L, Bramono K, Indriatmi W, Yunir E, Setiati S, Jusman SWA, Purwaningsih EH, Wibowo H, Danarti R. Oral and Topical Centella asiatica in Type 2 Diabetes Mellitus Patients with Dry Skin: A Three-Arm Prospective Randomized Double-Blind Controlled Trial. Evid Based Complement Alternat Med. 2020 Aug 26;2020:7253560. doi: 10.1155/2020/7253560. eCollection 2020.
- Background: PubMed 35664981Stettler H, Crowther JM, Brandt M, Boxshall A, Lu B, de Salvo R, Laing S, Hennighausen N, Bielfeldt S, Blenkiron P. Multi parametric biophysical assessment of treatment effects on xerotic skin. Skin Health Dis. 2021 Mar 21;1(2):e21. doi: 10.1002/ski2.21. eCollection 2021 Jun.
- Background: PubMed 27328437Serup J. EEMCO guidance for the assessment of dry skin (xerosis) and ichthyosis: clinical scoring systems. Skin Res Technol. 1995 Aug;1(3):109-14. doi: 10.1111/j.1600-0846.1995.tb00029.x.
- 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 Moisturizer Containing a Combination of 5% Hydro-Urea, Ceramide, with MultiVesicular Emulsion Technology and Petrolatum Ointment in people with Dry Skin in the Elderly, run by Dr. dr. Lili Legiawati, SpKK(K) 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 1 inclusion and 1 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 31 Jul 2026. 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?
Change in SRRC (time frame: Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07739355, which also lists 17 linked publications.
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 31 Jul 2026.