A 47 Hour Occlusive Cutaneous Skin Patch Test on Adult Subjects With Dry/Atopic Skin

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Eczema

Intervention / Treatment
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* Device: Eczema Repair Emollient


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who are able to give written informed consent and from whom written informed consent has been obtained Generally healthy male and female subjects between the ages of 18 and 65 years inclusive Subjects assessed by the dermatologist as having dry/atopic and very dry/ atopic skin Subjects who are able to understand the study, co-operate with the study procedures and are able to attend for all study assessments Exclusion Criteria: Subjects with active Psoriasis or other active skin disorders or with present skin tumours or malignant disease or a history of those Subjects taking antihistamine or corticoids, any medication for the treatment of diabetes mellitus, immuno-suppressive drugs or any other medication which in the opinion of the dermatologist may affect the test results. Subjects with active skin disorders or a history of skin disorders (e.g. psoriasis, eczema, vitiligo, pityriasis versicolor, acne) which in the opinion of the trainee dermatologist or SIT personnel may affect the test results

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eczema Emollient<br>Eczema Repair Emollient | Device: Eczema Repair Emollient<br>* An Emollient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |