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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2023-12-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Dermatitis, Atopic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

The moisturizer codes will be blinded (double-blind) until all study phases are completed. This ensures that the participants, investigators, and outcomes assessors are unaware of which intervention each participant is receiving during the study. This helps to minimize potential bias in the evaluation of the treatment outcomes.

Study Groups

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Aqua posae + microresyl

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

Group Type EXPERIMENTAL

Aqua posae and microresyl

Intervention Type OTHER

* 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.

10% Urea

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

Group Type ACTIVE_COMPARATOR

Urea 10%

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes