A 47 Hour Occlusive Cutaneous Skin Patch Test on Adult Subjects With Dry/Atopic Skin
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|ClinicalTrials.gov Identifier: NCT02620293|
Recruitment Status : Completed
First Posted : December 3, 2015
Last Update Posted : June 3, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Eczema||Device: Eczema Repair Emollient||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A 47 Hour, Single Application, Occlusive Forearm Skin Patch Test to Assess, Under Dermatological Control, the Acute Cutaneous Tolerance of Project Storm on the Forearm of Adult Subjects With Dry/Atopic and Very Dry/Atopic Skin|
|Study Start Date :||April 2016|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
Experimental: Eczema Emollient
Eczema Repair Emollient
Device: Eczema Repair Emollient
- Skin tolerance assessment using the ISO 10993 scoring system through visual assessment [ Time Frame: 47 hours ]Irritation of test products assessed using the Cutaneous Irritancy Index (scores range from <1 which is non-irritant to >4 strongly irritating
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02620293
|Skin Investigation Technology|
|Principal Investigator:||Dörte Segger, PhD||Skin Investigational Technology|