Cumulative Irritancy Patch Test (Cipt) of Ibuprofen 5% Topical Gel in Human Volunteers
Cumulative Irritancy Patch Test (Cipt) of Ibuprofen 5% Topical Gel in Human Volunteers
This study will determine the potential of Ibuprofen 5% Topical Gel and its vehicle gel to cause irritation after repeated topical application to the healthy skin of human subjects under controlled conditions.
Inclusion Criteria:
Healthy male and/or female subjects (to be confirmed by medical history) 18 years of age or older, female subjects of childbearing potential and males who are using an acceptable form of birth control, subjects who are free of any systemic or dermatologic disorder
Exclusion Criteria:
Have skin disease at the application site, not willing to stop use of systemic or topical analgesics, corticosteroids, or antihistamines, unwilling or unable to stop use of sunscreens, creams, or similar products on the back during the study