Pain
Conditions
Keywords
repeat insult patch test
Brief summary
This study is being conducted to determine the potential of Ibuprofen 5% Topical Gel and its vehicle gel to cause sensitization after repeated topical application to healthy skin of human subjects under controlled conditions.
Interventions
0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application
DRUGSodium lauryl sulfate 0.1%
0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application
0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Healthy male or female subjects 18 years of age or older, female subjects of childbearing potential and males are using an acceptable form of birth control, subjects are free of any systemic or dermatologic disorder
Exclusion criteria
Have any visible skin disease at the application site, not willing to stop use of systemic or topical analgesics, corticosteroids, or antihistamines, not willing to stop use of sunscreens, creams, or similar products on the back during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dermal sensitization potential | 24-72 hours after last patch removal |
Secondary
| Measure | Time frame |
|---|---|
| Cumulative Irritancy | 48-72 hours after each patch application |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | During study through 28 days after last product application |
Countries
United States
Outcome results
None listed