Atopic Dermatitis (AD), Mild and Moderate Atopic Dermatitis Patients
Conditions
Keywords
Steroid-sparing, Th2 cytokines, S. formosum-containing ointment, atopic dermatitis, clinical trial, Transepidermal water loss (TEWL), stratum corneum hydration (SCH), Scoring atopic dermatitis (SCORAD)
Brief summary
Atopic dermatitis (AD) is a chronic skin disorder, which negatively impacts up to 20% children and 3% adults in the world. The main AD treatments aim to regress clinical manifestations, improve and restore skin lesions. Daily moisturizing has also been shown to have the ability to protect the skin, increase skin elasticity and reduce the severity of AD. In the past few decades, Korea has been a well-known country with cosmetic companies and products derived from nature. Carboexpert is also one of them. Since its inception, the company has focused on researching and developing herbal extracts in skin care cosmetic products, typically the product Theraphytoabel Theraphyto Intensive-Cure Ointment. The product uses a high concentration of extract from Syzygium formosum (Wall) masam leaves originating from Vietnam. This is a medicinal herb that has been used in Vietnam for hundreds of years. Folk remedies in Vietnam use hot water leaf extract of this plant to treat urticaria and rashes. Previous studies have shown that leaf extract has also been shown to be very effective against gram-positive bacteria. The study in 2018 also demonstrated that the ethanol extract of S. formosum leaves was effective in reducing food allergy on mouse model. Based on the above evidences, this study will evaluate and compare the effectiveness and safety between Theraphytoabel Theraphyto Intensive-Cure Ointment product and commercial moisturizers which using in Vinmec on moderate and mild AD patients at Vinmec International Hospital Times City, Hanoi.
Interventions
OTHERS.formosum-containing ointment
The test ointment used in this study is Theraphytoabel Theraphyto Intensive-Cure Ointment (Carboexpert Inc., Daejeon, Korea), which contains various components, including herbal extracts. The content of S. Formosum leaf Extract is 0.35%
OTHERcommercial moisturizer
One of the moisturizers approved for use in patients with atopic dermatitis at Vinmec Times City
Sponsors
VinUniversity
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
* Age between 1 and 30 years of age * Definitive diagnosis of AD according to the Hanifin and Rajka criteria SCORAD scores: \< 25: mild AD, 26- 50: moderate AD * Total IgE and eosinophil measurements could be performed to access disease severity
Exclusion criteria
* Non-adherence to therapy * Presence of other active skin diseases * Severe AD within 1 month prior to enrollment * Any concomitant disease that in the investigators' judgment, could interdere with treatment * Current systemic treatment or use of immunosuppressive or immunomodulatory agents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical assessment of AD severity | week 0, 4, 8, 12 | AD global severity will be assessed using the SCORAD index, a validated clinical tool. The intensity of redness, swelling, oozing/ crusting, scratch marks, lichenification and dryness will be measured over the whole body. Subjective symptoms of itch and sleeplessness were measured and skin lesion photographs were taken at every visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of changes in transepidermal water loss | All patients will be measured at week 0 (baseline), 4, 8, 12. | Transepidermal water loss (TEWL) will be measured to assess changes in skin barrier function at baseline and after treatment using a moisturizer. Measurements will be performed on predefined lesional skin areas using GPSKIN barrier research solution 1 device (GPOWER Inc., Gyeonggi-do, South Korea) throughout the 12-week treatment, under standardized environmental conditions (room temperature 19-25°C and relative humidity 50-58%). Participants will be instructed to avoid applying topical products to the assessment site for at least 12 hours and to acclimatize in the examination room for 15 minutes before measurement. Three consecutive TEWL readings will be obtained at each assessment, and the mean value, expressed in g/m²/h, will be used for analysis. |
| Accessment the changes of Stratum corneum hydration (SCH) | week 0 (baseline), 4, 8, 12 | Stratum corneum hydration (SCH) will be assessed to evaluate changes in skin moisture content at baseline and after treatment using a moisturizer. Measurements will be performed on the same predefined lesional skin areas using GPSKIN barrier research solution 1 device (GPOWER Inc., Gyeonggi-do, South Korea) throughout the 12-week treatment, under standardized environmental conditions (room temperature 19-25°C and relative humidity 50-58%). Participants will be instructed to avoid applying topical products to the assessment site for at least 12 hours and to acclimatize in the examination room for 15-20 minutes before measurement. Three consecutive SCH readings will be obtained at each assessment, and the mean value, expressed in arbitrary units (a.u.) will be used for analysis. |
| Evaluate changes in cytokine levels | week 0, 12 | Cytokine levels of interleukin (IL)-4, IL-13, IL-5 and thymic stromal lymphopoietin (TSLP) in serum will be analyzed using ELISA cytokine kits, Duoset (Bio-Techne, Minneapolis, MN, USA) according to the manufacturer's recommendations. |
Countries
Vietnam
Outcome results
None listed