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NCT Number: NCT07739355

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

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.

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Key information

Conditions

Dry Skin in the Elderly

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universitas Indonesia, Jakarta Pusat, Jakarta 10430

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Petrolatum ointment

Drug

Vaseline album

Primary outcomes

  1. 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

  2. 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)

  3. 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

  4. 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.

  5. 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

  6. 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.

Sponsors and collaborators

Lead sponsor

Dr. dr. Lili Legiawati, SpKK(K)

Other

Collaborators

  • L'Oreal

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 31, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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