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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-04-30

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.

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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.

Conditions

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Eczema

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Eczema Emollient

Eczema Repair Emollient

Group Type EXPERIMENTAL

Eczema Repair Emollient

Intervention Type DEVICE

An Emollient

Interventions

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Eczema Repair Emollient

An Emollient

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No