Pain
Conditions
Keywords
cumulative irritancy patch test (CIPT)
Brief summary
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.
Interventions
DRUGIbuprofen 5% topical gel
0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions
0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions
DRUGSodium lauryl sulfate 0.2%
0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions
0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of local skin irritation at patch sites | Daily for 21 days, Days 2 through 22 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Days 1 through 22, + 28 days after last product administration |
Countries
United States
Outcome results
None listed