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| Name | Class |
|---|---|
| Skin Investigation Technology | INDUSTRY |
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This is an open label, non-comparative investigation to determine the tolerance of Eczema Repair Emollient on healthy subjects with dry/atopic and very dry/atopic skin.
The Eczema Repair Emollient will be applied for 47 hours under occlusion. Skin tolerance will be assessed immediately and 1 hour, 24, 48 and 72 hours after patch removal.
At immediate, 1, 24, 48, and 72 hours post-test patch removal (date & time of each assessment will be recorded), each test site will be scored for erythema and oedema by the trained investigator using the ISO 10993 scoring system.
Primary Endpoint The irritation of the test product according to the Cutaneous Irritancy Index value. The test product should be graded as 'non-irritant' and confirmed by the study dermatologist.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eczema Emollient | Experimental | Eczema Repair Emollient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eczema Repair Emollient | Device | An Emollient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Skin tolerance assessment using the ISO 10993 scoring system through visual assessment | Irritation of test products assessed using the Cutaneous Irritancy Index (scores range from <1 which is non-irritant to >4 strongly irritating | 47 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dörte Segger, PhD | Skin Investigational Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin Investigation Technology | Hamburg | Germany |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 6, 2017 | |
| Unrelease | Yes | |
| Release | Apr 12, 2018 | |
| Reset | Nov 9, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 6, 2017 | Yes | |||
| Apr 12, 2018 |
| ID | Term |
|---|---|
| D004485 | Eczema |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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| Nov 9, 2018 |