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

Phase 1

Completed

• Conditions: Eczema
• Interventions: Device: Eczema Repair Emollient

• Registration Number: NCT02620293
• Lead Sponsor: Reckitt Benckiser Healthcare (UK) Limited

Brief Summary

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

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 Timeline

• Study First Submitted: 2015-09-09
• Study First Submitted QC: 2015-11-30
• Study First Posted: 2015-12-03
• Study Start: 2016-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-06-02
• Last Update Posted: 2016-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Eczema Emollient	Eczema Repair Emollient	Eczema Repair Emollient

Primary Outcome Measures

Name	Time	Method
Skin tolerance assessment using the ISO 10993 scoring system through visual assessment	47 hours	Irritation of test products assessed using the Cutaneous Irritancy Index (scores range from \<1 which is non-irritant to \>4 strongly irritating

Trial Locations

Locations (1)

Skin Investigation Technology; 🇩🇪 Hamburg, Germany