Dermatitis, Atopic
Conditions
Keywords
atopic dermatitis, skin barrier, moisturizer, bacterial lysate, clinical efficacy
Brief 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.
Interventions
OTHERAqua 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.
OTHERUrea 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
L'Oreal
Dr. Soetomo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SCORAD (Scoring Atopic Dermatitis) | 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) |
| PVAS (Pruritus Visual Analog Scale) | 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). |
| EASI (Eczema Area and Severity Index) | 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 |
| DLQI (Dermatology Life Quality Index) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin Hydration | 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.). |
| Skin pH | 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. |
| Transepidermal Water Loss (TEWL) | 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. |
Countries
Indonesia
Outcome results
None listed