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A 24 Hour Occlusive Single Patch Test to Assess Acute Tolerance of Pre Lubricated Condom on a Panel of Healthy Adult Subjects

Healthy Clinical Trial

Official title:
A 24 Hour Occlusive Single Patch Test to Assess, Under Dermatological Control, the Acute Cutaneous Tolerance of Pre Lubricated Kiss Condom on a Panel of Healthy Adult Subjects

Clinical Trial Summary

This is a 24 hour patch test to determine the acute tolerance of 3 variants of condom on a panel of healthy adult subjects. The patches will be affixed to the back and remain under occlusion for 24 hours. They will then be assessed at 30 minutes and 24 hours post patch removal.

Clinical Trial Description

Three test products (plus positive and negative control) will be applied to the back using occlusive tape and will remain on the skin for 24 hours. The patches will be removed after 24 hours and assessed as 30 minutes post patch removal and again at 24 hours post patch removal. Each test site will be scored for erythema and oedema by a dermatologist.

The primary endpoint for this Clinical Investigation is the irritation of the test products according to the Cutaneous Irritancy Index value. The test products success criteria is to be graded as 'non-irritant' and this should be confirmed by the study dermatologist. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02864966
Study type Interventional
Source Reckitt Benckiser Healthcare (UK) Limited
Contact
Status Completed
Phase N/A
Start date May 2016
Completion date May 2016
View Details
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