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

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ClinicalTrials.gov Identifier: NCT02620293
Recruitment Status : Completed
First Posted : December 3, 2015
Last Update Posted : June 3, 2016
Sponsor:
Collaborator:
Skin Investigation Technology
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Eczema Device: Eczema Repair Emollient Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Study Start Date : April 2016
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Eczema Emollient
Eczema Repair Emollient
Device: Eczema Repair Emollient
An Emollient




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02620293


Locations
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Germany
Skin Investigation Technology
Hamburg, Germany
Sponsors and Collaborators
Reckitt Benckiser Healthcare (UK) Limited
Skin Investigation Technology
Investigators
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Principal Investigator: Dörte Segger, PhD Skin Investigational Technology

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Responsible Party: Reckitt Benckiser Healthcare (UK) Limited
ClinicalTrials.gov Identifier: NCT02620293     History of Changes
Other Study ID Numbers: 09224-01
First Posted: December 3, 2015    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
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Emollients
Dermatologic Agents