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

Dr. Soetomo General Hospital

Status: Completed

Conditions: Dermatitis, Atopic

Treatments: Other: Aqua posae and microresyl; Other: Urea 10%

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06553417

2141/112/2/V/2023

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Aqua posae + microresyl

Experimental group

Description:

• Participants in this arm will receive the moisturizer formulation containing aqua posae and microresyl.

Treatment:

Other: Aqua posae and microresyl

10% Urea

Active Comparator group

Description:

• Participants in this arm will receive the moisturizer formulation containing 10% urea.

Treatment:

Other: Urea 10%