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| ID | Type | Description | Link |
|---|---|---|---|
| 24.10.VVI | Other Grant/Funding Number | Chungnam National University, CarboExpert INC. |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Commercial group | Active Comparator | Commercial moisturizer group will be applied standard therapy by topical commercial moisturizers using in Vinmec combined with or without topical corticosteroids within 3 months. During this period, any patients have exacerbation, they will be treated rescue therapy as prescription with or without topical corticosteroids. |
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| Theraphyto group | Experimental | S. formosum-containing ointment group will be applied standard therapy by topical Theraphytoabel Theraphyto Intensive-Cure Ointment combined with or without topical corticosteroids within 3 months. During this period, any patients have exacerbation, they will be treated rescue therapy as prescription with topical corticosteroids. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S.formosum-containing ointment | Other | 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% |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical assessment of AD severity | 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. | week 0, 4, 8, 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of changes in transepidermal water loss | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety of the products on AD patient | Adverse events will be categorized as local or systemic and will be graded according to severity. Mild local adverse events will include feelings of stickiness after application, changes in clothing color, and increased sensitivity to sunlight. Moderate local adverse events will include sensitive skin irritation (e.g., itching, stinging, and burning sensations), irritant contact dermatitis characterized by erythema, mild edema, and scaling, allergic contact dermatitis presenting with erythema, vesiculation, edema, and bullae formation, as well as contact urticaria. Severe local adverse events will include eczema. Mild systemic adverse events will include headache, nausea, and dizziness. Moderate systemic adverse events will include dyspnea, while severe systemic adverse events will include anaphylaxis. All adverse events will be monitored throughout the study and will be recorded according to their severity and their potential relationship to the study treatment. |
Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vinmec - VinUni Institute of Immunology, VinUniversity | Hanoi | Vietnam |
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| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| commercial moisturizer | Other | One of the moisturizers approved for use in patients with atopic dermatitis at Vinmec Times City |
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| All patients will be measured at week 0 (baseline), 4, 8, 12. |
| Accessment the changes of Stratum corneum hydration (SCH) | 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. | week 0 (baseline), 4, 8, 12 |
| Evaluate changes in cytokine levels | 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. | week 0, 12 |
| Week 4, 8, 12 |
| Evaluate patient's satisfaction after using product | A survey of satisfaction after using products will be collected from all patients in both groups. The detail of survey will be description in Appendix 05. Total score will be collected and classified base on the scale such as 0-5: unsatisfied, 6-15: normal, 16-24: satisfied. | week 12 |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |