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| Name | Class |
|---|---|
| L'Oreal | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aqua posae + microresyl | Experimental | • Participants in this arm will receive the moisturizer formulation containing aqua posae and microresyl. |
|
| 10% Urea | Active Comparator | • Participants in this arm will receive the moisturizer formulation containing 10% urea. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aqua posae and microresyl | Other |
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. |
| Measure | Description | Time Frame |
|---|---|---|
| SCORAD (Scoring Atopic Dermatitis) |
| Through study completion, 12 week |
| PVAS (Pruritus Visual Analog Scale) |
| Through study completion, 12 week |
| EASI (Eczema Area and Severity Index) |
| Through study completion, 12 week |
| DLQI (Dermatology Life Quality Index) |
| Through study completion, 12 week |
| Measure | Description | Time Frame |
|---|---|---|
| Transepidermal Water Loss (TEWL) |
| Through study completion, 12 week |
| Skin Hydration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Soetomo General Hospital | Surabaya | East Java | 60286 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22310478 | Background | Kong HH, Oh J, Deming C, Conlan S, Grice EA, Beatson MA, Nomicos E, Polley EC, Komarow HD; NISC Comparative Sequence Program; Murray PR, Turner ML, Segre JA. Temporal shifts in the skin microbiome associated with disease flares and treatment in children with atopic dermatitis. Genome Res. 2012 May;22(5):850-9. doi: 10.1101/gr.131029.111. Epub 2012 Feb 6. | |
| 37092256 |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| C485040 | N,N'-11-bis((1Z,4Z)-7alphaH-germacra-1(10),4-dienyl)urea |
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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.
|
| Urea 10% | Other | Intervention 2: Urea 10%
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. |
|
| Through study completion, 12 week |
| Skin pH |
| Through study completion, 12 week |
| Zelenkova H, Kerob D, Salah S, Demessant-Flavigny AL. Impact of daily use of emollient 'plus' on corticosteroid consumption in patients with atopic dermatitis: An open, randomized controlled study. J Eur Acad Dermatol Venereol. 2023 Jun;37 Suppl 5:27-34. doi: 10.1111/jdv.18947. Epub 2023 Apr 24. |
| 29676534 | Background | Wollenberg A, Barbarot S, Bieber T, Christen-Zaech S, Deleuran M, Fink-Wagner A, Gieler U, Girolomoni G, Lau S, Muraro A, Czarnecka-Operacz M, Schafer T, Schmid-Grendelmeier P, Simon D, Szalai Z, Szepietowski JC, Taieb A, Torrelo A, Werfel T, Ring J; European Dermatology Forum (EDF), the European Academy of Dermatology and Venereology (EADV), the European Academy of Allergy and Clinical Immunology (EAACI), the European Task Force on Atopic Dermatitis (ETFAD), European Federation of Allergy and Airways Diseases Patients' Associations (EFA), the European Society for Dermatology and Psychiatry (ESDaP), the European Society of Pediatric Dermatology (ESPD), Global Allergy and Asthma European Network (GA2LEN) and the European Union of Medical Specialists (UEMS). Consensus-based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part I. J Eur Acad Dermatol Venereol. 2018 May;32(5):657-682. doi: 10.1111/jdv.14891. |
| 38553927 | Background | Ch'ng CC. Rebalancing of the skin microbiome with an emollient 'plus' for effective management of atopic dermatitis: A mini review. Med J Malaysia. 2024 Mar;79(2):203-205. |
| 18795916 | Background | Gueniche A, Knaudt B, Schuck E, Volz T, Bastien P, Martin R, Rocken M, Breton L, Biedermann T. Effects of nonpathogenic gram-negative bacterium Vitreoscilla filiformis lysate on atopic dermatitis: a prospective, randomized, double-blind, placebo-controlled clinical study. Br J Dermatol. 2008 Dec;159(6):1357-63. doi: 10.1111/j.1365-2133.2008.08836.x. Epub 2008 Sep 15. |
| 37328919 | Background | Wollenberg A, Kinberger M, Arents B, Aszodi N, Barbarot S, Bieber T, Brough HA, Pinton PC, Christen-Zaech S, Deleuran M, Dittmann M, Fosse N, Gaspar K, Gerbens LAA, Gieler U, Girolomoni G, Gregoriou S, Mortz CG, Nast A, Nygaard U, Rehbinder EM, Ring J, Rossi M, Roxburgh C, Serra-Baldrich E, Simon D, Szalai ZZ, Szepietowski JC, Torrelo A, Werfel T, Flohr C. First update of the living European guideline (EuroGuiDerm) on atopic eczema. J Eur Acad Dermatol Venereol. 2023 Nov;37(11):e1283-e1287. doi: 10.1111/jdv.19269. Epub 2023 Jul 17. No abstract available. |
| 28138262 | Background | Seite S, Zelenkova H, Martin R. Clinical efficacy of emollients in atopic dermatitis patients - relationship with the skin microbiota modification. Clin Cosmet Investig Dermatol. 2017 Jan 12;10:25-33. doi: 10.2147/CCID.S121910. eCollection 2017. |
| 37092275 | Background | Magnolo N, Jaenicke T, Tsianakas A, Czech W, Thaci D, Pinter A, Kerob D, Salah S, Luger TA. Comparison of different skin care regimens in patients with moderate to severe atopic dermatitis receiving systemic treatment: A randomized controlled trial. J Eur Acad Dermatol Venereol. 2023 Jun;37 Suppl 5:18-26. doi: 10.1111/jdv.18949. Epub 2023 Apr 24. |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |