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

Reckitt Benckiser

Status and phase: Completed; Phase 1

Conditions: Eczema

Treatments: Device: Eczema Repair Emollient

Study type: Interventional

Funder types: Industry

Identifiers

NCT02620293

09224-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

33 participants in 1 patient group

Eczema Emollient

Experimental group

Description:

Eczema Repair Emollient

Treatment:

Device: Eczema Repair Emollient