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

NCT06553417 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-08-14

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • L'Oreal

    collaborator INDUSTRY

  • Dr. Soetomo General Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2023-09-29
Completion
2023-12-29

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06553417 on ClinicalTrials.gov