NCT06553417

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Dr. Soetomo General Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
OTHER	Aqua posae and microresyl	* 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.
OTHER	Urea 10%	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.

Timeline

• Start date: 2023-06-01
• Primary completion: 2023-09-29
• Completion: 2023-12-29
• First posted: 2024-08-14
• Last updated: 2024-08-14

Locations

1 site across 1 country: Indonesia