RIPT of Ibuprofen Topical Gel

• Drug: Topical gel vehicle
  
  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
• Drug: Sodium 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
• Drug: Sodium chloride solution 0.9% (saline)
  
  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

• Experimental: Ibuprofen 5% topical gel
  
  Intervention: Drug: Topical gel vehicle
• Experimental: Topical gel vehicle
  
  Intervention: Drug: Topical gel vehicle
• Active Comparator: Sodium lauryl sulfate 0.1%
  
  Intervention: Drug: Sodium lauryl sulfate 0.1%
• Sham Comparator: Sodium chloride solution 0.9% (saline)
  
  Intervention: Drug: Sodium chloride solution 0.9% (saline)

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