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.
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 Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
33
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.
Alba Science Ltd
Edinburgh, United Kingdom
The primary endpoint is the irritation of the test products according to the Cutaneous Irritancy Index value. The test products are expected to be graded as 'non-irritant' as confirmed by a dermatologist.
Acute tolerance study to test the safety of a new condom on healthy adult skin.
Time frame: 24 hours
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