NCT02864966

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Reckitt Benckiser Healthcare (UK) Limited · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	Condom	This study involves testing a condom, however the device will not be used as intended. The device will be destroyed to make the test patches required for this safety study.

Timeline

• Start date: 2016-05-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2016-08-12
• Last updated: 2016-09-09

Locations

1 site across 1 country: United Kingdom