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| Name | Class |
|---|---|
| Samara State Medical University | OTHER |
| Prof. Zvulunov Alex, Pediatric Dermatology Clinic, Kfar-Saba, Israel. | UNKNOWN |
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A Double-Blind Randomized Placebo-Controlled Trial to Evaluate the Efficacy of the "Атопик Soothing Cream" in Children with Mild to Moderate Atopic Dermatitis
"Атопик Soothing Cream" is a lipid complex composed of barley grain, Butyrospermum Parkii and Argania Spinosa Kernel oil, in a mixture with panthenol and bisabolol.
Investigators concure that combination of these substances in "Атопик Soothing Cream" will be efficacious non-steroidal treatment of Atopic Dermatiti ( AD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Атопик" phase 1 | Active Comparator | For the first phase of the study, subjects will be randomized to receive treatment with "Атопик Soothing Cream". |
|
| Placebo - phase 1 | Placebo Comparator | For the first phase of the study, subjects will be randomized to receive treatment with Placebo Cream. |
|
| "Атопик" phase 2 | Active Comparator | The second phase of the study is an open-label extension with all subjects receiving "Атопик Soothing Cream". |
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| Placebo - phase 2 | Placebo Comparator | The second phase of the study is an open-label extension with all subjects receiving "Атопик Soothing Cream". |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Атопик Soothing Cream" | Device | Topical application of a study cream to involved skin areas twice a day. |
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| Measure | Description | Time Frame |
|---|---|---|
| Investigators' Global Assessment score | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Eczema Area & Severity Index (EASI) | 28 days | |
| Pruritus intensity | Visual Analog Scale | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Trans-Epidermal Water Loss | 28 days | |
| Stratum Corneum Capacitance | 28 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alex Zvulunov, MD | Prof. Alex Zvulunov, Pediatric Dermatology Clinic, Israel | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Allergy-Immunology, Department of Pediatrics, Institute of Professional Education | Samara | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24894548 | Background | Maurya AK, Singh M, Dubey V, Srivastava S, Luqman S, Bawankule DU. alpha-(-)-bisabolol reduces pro-inflammatory cytokine production and ameliorates skin inflammation. Curr Pharm Biotechnol. 2014;15(2):173-81. doi: 10.2174/1389201015666140528152946. | |
| 12113650 | Background | Ebner F, Heller A, Rippke F, Tausch I. Topical use of dexpanthenol in skin disorders. Am J Clin Dermatol. 2002;3(6):427-33. doi: 10.2165/00128071-200203060-00005. |
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Clinical parameters at the entry and at the end of study might be shared.
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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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| Placebo | Device | Topical application of a study placebo cream to involved skin areas twice a day. |
|
| 25345257 | Result | Jirabundansuk P, Ophaswongse S, Udompataikul M. Comparative trial of moisturizer containing spent grain wax, Butyrospermum parkii extract, Argania spinosa kernel oil vs. 1% hydrocortisone cream in the treatment of childhood atopic dermatitis. J Med Assoc Thai. 2014 Aug;97(8):820-6. |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |