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

Dr. Soetomo General Hospital60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Dermatitis, Atopic

Interventions

Aqua posae and microresylOTHER

* 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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Dr. Soetomo General Hospital

Surabaya, East Java, Indonesia

Outcomes

Primary Outcomes

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)