Emollient 'Plus' vs Urea 10% for Mild-Moderate Atopic Dermatitis
NCT Number: NCT06553417
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dermatitis, Atopic
Interventions: OTHER: Aqua posae and microresyl|OTHER: Urea 10%
Sponsor: Dr. Soetomo General Hospital
Collaborators: L'Oreal
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-06-01
Completion Date: 2023-12-29
Locations: Dr. Soetomo General Hospital, Surabaya, East Java, 60286, Indonesia

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.

Primary Outcome Measures: SCORAD (Scoring Atopic Dermatitis), * 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), Through study completion, 12 week|PVAS (Pruritus Visual Analog Scale), * 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)., Through study completion, 12 week|EASI (Eczema Area and Severity Index), * 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, Through study completion, 12 week|DLQI (Dermatology Life Quality Index), * 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., Through study completion, 12 week
Secondary Outcome Measures: Transepidermal Water Loss (TEWL), * 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., Through study completion, 12 week|Skin Hydration, * 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.)., Through study completion, 12 week|Skin pH, * 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., Through study completion, 12 week