Skip to main content
OpenTrials
Completed

NCT Number: NCT06553417

Emollient 'Plus' vs Urea 10% for Mild-Moderate Atopic Dermatitis

The goal of this clinical trial is to evaluate the effectiveness and tolerability of an Emollient Aqua Posae + Microesyl compared to urea 10% in patients with mild-moderate atopic dermatitis The main question it aims to answer is:

" To evaluate the effectiveness and tolerability of an Emollient Aqua Posae + Microesyl compared to urea 10% in patients with mild-moderate atopic dermatitis age 18 years and above". Moisturizer application will be performed twice daily, 3 minutes after bathing, with a standardized dose using the Finger Tip Unit (FTU) method.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dermatitis, Atopic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Soetomo General Hospital

Surabaya, East Java, 60286, Indonesia

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female aged ≥18 years
  • AD patients who meet the criteria for AD diagnosis according to the Hanifin-Rajka criteria.
  • Patients with mild-moderate AD according to the SCORAD index.
  • Patients who have AD lesions on the hands and/or feet.
  • Patients with good general condition.
  • Patients are willing to participate in the study and sign the informed consent.

Exclusion criteria

  • Pregnant and lactating patients.
  • Patients with a history of allergies to ingredients contained in moisturizers
  • Patients who clinically have other skin diseases such as psoriasis, seborrheic dermatitis, contact dermatitis or AD with secondary infections that can affect the SCORAD index parameters, skin hydration, skin pH and side effects on the skin area being assessed.
  • Patients receiving topical or systemic immunomodulatory and/or immunosuppressant therapy.
  • Patients receiving topical and/or systemic antibiotic therapy
  • Patients receiving systemic antihistamine therapy (patients who require antihistamines during the study will be recorded on the observation sheet)

Treatment and study plan

Aqua posae and microresyl

Other
  • This intervention involves the use of two topical products:
  • Aqua posae - a moisturizing agent
  • Microresyl - an active ingredient with potential therapeutic effects
  • Subjects in Group A will be instructed to apply these two products (aqua posae and microresyl) twice daily to the upper and lower limbs, including both lesional and non-lesional areas of the skin.

The use of these interventions will be evaluated over a 12-week period, with assessments of Transepidermal Water Loss (TEWL), skin hydration, skin pH, index scoring of atopic dermatitis (SCORAD), erythema area severity index (EASI), pruritus visual analogue scale (PVAS), quality of life (DLQI), and any adverse effects.

Urea 10%

Other

Intervention 2: Urea 10%

  • This intervention involves the use of a 10% urea-based topical moisturizing product.
  • Subjects in Group B will be instructed to apply the 10% urea moisturizer twice daily to the upper and lower limbs, including both lesional and non-lesional areas of the skin.

The use of these interventions will be evaluated over a 12-week period, with assessments of Transepidermal Water Loss (TEWL), skin hydration, skin pH, index scoring of atopic dermatitis (SCORAD), erythema area severity index (EASI), pruritus visual analogue scale (PVAS), quality of life (DLQI), and any adverse effects.

Primary outcomes

  1. SCORAD (Scoring Atopic Dermatitis)

    Time frame: Through study completion, 12 week

    • The SCORAD is a composite score that evaluates the extent and severity of atopic dermatitis.
    • The SCORAD scale ranges from 0 to 103, with higher scores indicating more severe disease. The ranges of the SCORAD (0-25 for 'mild' disease, and 25-50 for 'moderate' disease, >50 for severe disease)

  2. PVAS (Pruritus Visual Analog Scale)

    Time frame: Through study completion, 12 week

    • The PVAS is a 100 mm visual analog scale that assesses the severity of pruritus (itching) experienced by the patient.
    • The PVAS ranges from 0 (no itch) to 100 (worst imaginable itch).

  3. EASI (Eczema Area and Severity Index)

    Time frame: Through study completion, 12 week

    • The EASI is a tool that measures the extent and severity of atopic dermatitis lesions.
    • The EASI score ranges from 0 to 72, with higher scores indicating more severe disease. 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe

  4. DLQI (Dermatology Life Quality Index)

    Time frame: Through study completion, 12 week

    • The DLQI is a questionnaire that assesses the impact of skin diseases on a patient's quality of life.
    • The DLQI score ranges from 0 to 30, with higher scores indicating a greater impairment of quality of life.

Secondary outcomes

  1. Transepidermal Water Loss (TEWL)

    Time frame: Through study completion, 12 week

    • TEWL is a measure of the barrier function of the skin, with higher values indicating a more compromised skin barrier.
    • TEWL is typically measured in g/m^2/h.

  2. Skin Hydration

    Time frame: Through study completion, 12 week

    • Skin hydration is a measure of the moisture content of the skin, with higher values indicating more hydrated skin.
    • Skin hydration is typically measured using corneometry, with the values reported in arbitrary units (a.u.).

  3. Skin pH

    Time frame: Through study completion, 12 week

    • Skin pH is a measure of the acidity of the skin surface, with normal skin having a slightly acidic pH around 5.5.
    • Skin pH is measured on a scale from 0 to 14, with lower values indicating more acidic skin.

Sponsors and collaborators

Lead sponsor

Dr. Soetomo General Hospital

Other Gov

Collaborators

  • L'Oreal

Registry information

Official study title

Effectiveness and Tolerability of an Emollient 'Plus' Compared to Urea 10% in Patients With Mild-moderate Atopic Dermatitis

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 14, 2024
Registry last updated
Aug 14, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.