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

August 11, 2024 updated by: Dr. Soetomo General Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • East Java
      • Surabaya, East Java, Indonesia, 60286
        • Dr. Soetomo General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aqua posae + microresyl
• Participants in this arm will receive the moisturizer formulation containing aqua posae and microresyl.
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.
Active Comparator: 10% Urea
• Participants in this arm will receive the moisturizer formulation containing 10% urea.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SCORAD (Scoring Atopic Dermatitis)
Time Frame: Through study completion, 12 week
  • 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)
Time Frame: Through study completion, 12 week
  • 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)
Time Frame: Through study completion, 12 week
  • 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)
Time Frame: Through study completion, 12 week
  • 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

Outcome Measure
Measure Description
Time Frame
Transepidermal Water Loss (TEWL)
Time Frame: Through study completion, 12 week
  • 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
Time Frame: Through study completion, 12 week
  • 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
Time Frame: Through study completion, 12 week
  • 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Soetomo General Hospital

Collaborators

L'Oreal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

September 29, 2023

Study Completion (Actual)

December 29, 2023

Study Registration Dates

First Submitted

August 8, 2024

First Submitted That Met QC Criteria

August 11, 2024

First Posted (Actual)

August 14, 2024

Study Record Updates

Last Update Posted (Actual)

August 14, 2024

Last Update Submitted That Met QC Criteria

August 11, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2141/112/2/V/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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