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NCT Number: NCT04127513

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

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.

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Key information

Conditions

Xerosis Cutis

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Medicine University of Indonesia

Jakarta Pusat, DKI Jakarta, 10340, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Ammonium Lactate

Drug

12% ammonium lactate moisturizing cream

urea

Drug

10% urea moisturizing cream

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 15, 2019
Registry last updated
Oct 15, 2019

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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