Emollient 'Plus' vs Urea 10% for Mild-Moderate Atopic Dermatitis
- Conditions
- Dermatitis, Atopic
- Interventions
- Other: Urea 10%Other: Aqua posae and microresyl
- Registration Number
- NCT06553417
- Lead Sponsor
- Dr. Soetomo General Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 10% Urea Urea 10% • Participants in this arm will receive the moisturizer formulation containing 10% urea. Aqua posae + microresyl Aqua posae and microresyl • Participants in this arm will receive the moisturizer formulation containing aqua posae and microresyl.
- Primary Outcome Measures
Name Time Method SCORAD (Scoring Atopic Dermatitis) 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)DLQI (Dermatology Life Quality Index) 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.EASI (Eczema Area and Severity Index) 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 severePVAS (Pruritus Visual Analog Scale) 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).
- Secondary Outcome Measures
Name Time Method Skin Hydration 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.).Transepidermal Water Loss (TEWL) 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.Skin pH 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.
Trial Locations
- Locations (1)
Dr. Soetomo General Hospital
🇮🇩Surabaya, East Java, Indonesia