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

NCT07739355 | Completed Phase 3

• 1 other identifier: KET-1521UN2.F1ETIKPPM00022025
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dry Skin in the Elderly

Keywords

ceramides; dry skin; elderly; multivesicular emulsion technology; urea

Outcome Measures

Primary Outcomes (6)

• 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

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

• Change in Skin Capacitance

  SCap measured in (AU)

  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

  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.

  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

  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.

  Assessed throughout the 31-day observation period

Study Arms (2)

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

Drug: Moisturizer Containing a Combination of 5% Hydro-Urea, Ceramide, with MultiVesicular Emulsion Technology

Petrolatum

ACTIVE COMPARATOR

Petrolatum twice a day

Drug: Petrolatum Ointment

Interventions

Moisturizer Containing a Combination of 5% Hydro-Urea, Ceramide, with MultiVesicular Emulsion Technology DRUG

Moisturizer Containing a Combination of 5% Hydro-Urea, Ceramide, with MultiVesicular Emulsion Technology

Moisturizer containing a combination of 5% hydro-urea, ceramides, with MVE technology

Petrolatum Ointment DRUG

Vaseline album

Petrolatum

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. dr. Lili Legiawati, SpKK(K): lead
• L'Oreal: collaborator

Study Sites (1)

Universitas Indonesia, Jakarta Pusat, Jakarta 10430

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

Related Publications (17)

• 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.

  PMID: 32671664 BACKGROUND

• Spada 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.

  PMID: 30410378 BACKGROUND

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  PMID: 16268870 BACKGROUND

• Yahya 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

• 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.

  PMID: 9498022 BACKGROUND

• Pan 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.

  PMID: 24314769 BACKGROUND

• Draelos 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.

  PMID: 32272513 BACKGROUND

• Badan Pusat Statistik. Statistik Indonesia 2025: Statistical Yearbook of Indonesia 2025. Vol 53. Jakarta: Badan Pusat Statistik; 2025.

  BACKGROUND

• 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.

  PMID: 31940044 BACKGROUND

• Legiawati 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.

  PMID: 32908567 BACKGROUND

• Stettler 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.

  PMID: 35664981 BACKGROUND

• Serup 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.

  PMID: 27328437 BACKGROUND

• Norman 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.

  PMID: 14510882 BACKGROUND

• Widaty 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.

  BACKGROUND

• 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.

  PMID: 22104182 BACKGROUND

• Republic of Indonesia Ministry of Health. The Situation of the Elderly in Indonesia and Access to Social Protection Programs: Secondary Data Analysis [Internet]. 2020. 41 p. Available from: www.tnp2k.go.id

  BACKGROUND

• Sánchez-Álvarez I, Arellano-Mendoza MI, García L. Geriatric dermatology, changes related to aging. Rev Medica del Hosp Gen Mexico. 2019;82(3):158-68.

  BACKGROUND

MeSH Terms

Interventions

Ceramides

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Neutral Glycosphingolipids; Glycosphingolipids; Glycolipids; Glycoconjugates; Carbohydrates; Lipids; Sphingolipids; Membrane Lipids

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start: November 10, 2025
• Primary Completion: December 11, 2025
• Study Completion: December 11, 2025
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)