Dermal Safety Study to Evaluate the Sensitizing Potential of Abametapir Lotion

Exclusion Criteria

• •1. Have any visible skin disease at the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction;
• •2. Are not willing to refrain from using topical/systemic analgesics such as aspirin (daily use of 81 mg aspirin is acceptable), Aleve, Motrin, Advil, or Nuprin for 72 hours prior to and during the study (occasional use of acetaminophen will be permitted);
• •3. Are using inhaled/systemic/topical corticosteroids in the 3 weeks prior to and during the study, or systemic/topical antihistamines for 72 hours prior to and during the study;
• •4. Are using medication which, in the opinion of the investigative personnel, will interfere with the study results, including anti-inflammatory medications;
• •5. Are unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions, or similar products on the back during the study;
• •6. Have psoriasis and/or active atopic dermatitis/eczema;
• •7. Are females who are pregnant, plan to become pregnant during the study, or are breast-feeding a child;
• •8. Have a known sensitivity to constituents present in the material being evaluated;
• •9. Have damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site;
• •10. Have received treatment for any type of internal cancer within 5 years prior to study entry;
• •11. Have a history of, or are currently being treated for skin cancer;
• •12. Are currently participating in any other clinical trial;
• •13. Have any known sensitivity to adhesives; and/or
• •14. Have received any investigational treatment(s) within 4 weeks prior to study entry.