Status and phase
Conditions
Treatments
About
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.
Enrollment
Sex
Ages
Volunteers
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
Primary purpose
Allocation
Interventional model
Masking
50 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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