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Completed

NCT Number: NCT02620293

A 47 Hour Occlusive Cutaneous Skin Patch Test on Adult Subjects With 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.

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Key information

Conditions

Eczema Dermatitis Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Skin Investigation Technology

Hamburg, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eczema Repair Emollient

Device

An Emollient

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Reckitt Benckiser Healthcare (UK) Limited

Industry

Collaborators

  • Skin Investigation Technology

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 3, 2015
Registry last updated
Jun 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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