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

Eczema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02620293
• Other study ID #: 09224-01
• Status: Completed
• Phase: Phase 1
• First received: September 9, 2015
• Last updated: June 2, 2016
• Start date: April 2016
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: Reckitt Benckiser Healthcare (UK) Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Eczema

Intervention

Device:
• Eczema Repair Emollient
An Emollient

Locations

Country	Name	City	State
Germany	Skin Investigation Technology	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Reckitt Benckiser Healthcare (UK) Limited	Skin Investigation Technology

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes