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The main purpose of this study is to demonstrate the safety and efficacy of KAM2904 Face Cream and KAM3008 Body Lotion in reducing the symptoms of mild to moderate AD. Efficacy will be evaluated by comparing SCORAD and Eczema Area Severity Index (EASI) in a group of subjects treated with KAM2904 Face Cream and KAM3008 Body Lotion (the treatment group), versus a group of subjects treated with a petrolatum-based moisturizer (the control group). Safety will be determined by the number and severity of Adverse Events Device-Related.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KAM2904 Face Cream and KAM3008 Body Lotion | Experimental | A group treated with KAM2904 Face Cream and KAM3008 Body Lotion |
|
| petrolatum-based moisturizer | Sham Comparator | control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KAM2904 Face Cream | Device |
| ||
| KAM3008 Body Lotion |
| Measure | Description | Time Frame |
|---|---|---|
| • Change in SCORAD (Scoring Atopic Dermatitis) | after 42 days of treatment | |
| • Change in EASI (Eczema Area Severity Index) | after 42 days of treatment | |
| • Change in the scoring of individual symptoms of atopic dermatitis | after 42 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| • Trend in the change of SCORAD | after 42 days of treatment | |
| • Trend in the change of EASI | after 42 days of treatment | |
| • Trend in the change of individual symptoms of atopic dermatitis |
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Inclusion Criteria:
• Male or female between 2 and 12 years of age
Exclusion Criteria:
• The subject has another dermatological disease/condition that could interfere with the clinical evaluation, including infected atopic dermatitis lesions
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miri Sani | Contact | mirisani@013.net |
| Name | Affiliation | Role |
|---|---|---|
| Prof. Eli Sprecher, MD | Tel Aviv Soraski Medical Center - Dermatology Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundación Teknon | Recruiting | Barcelona | Spain |
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| Label | URL |
|---|---|
| Sponsor's site | View source |
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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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| Device |
|
| petrolatum-based moisturizer | Other |
|
| after 42 days of treatment |
| • Safety of KAM2904 Face Cream and KAM3008 Body Lotion | Safety will be measured by the number and severity of Device-Related Adverse Events. | days D14, D28, D42 and unscheduled visits |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |