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

June 2, 2016 updated by: Reckitt Benckiser Healthcare (UK) Limited

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany
        • Skin Investigation Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eczema Emollient
Eczema Repair Emollient
Device: Eczema Repair Emollient
An Emollient

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Reckitt Benckiser Healthcare (UK) Limited

Collaborators

Skin Investigation Technology

Investigators

  • Principal Investigator: Dörte Segger, PhD, Skin Investigational Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

September 9, 2015

First Submitted That Met QC Criteria

November 30, 2015

First Posted (Estimate)

December 3, 2015

Study Record Updates

Last Update Posted (Estimate)

June 3, 2016

Last Update Submitted That Met QC Criteria

June 2, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09224-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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