Skin Irritation Potential of MOB015B in Healthy Subjects Using a Cumulative Irritant Patch Test Design

Exclusion Criteria

• •1. Has any visible skin disease at the application site which, in the opinion of the Investigator, will interfere with the evaluation of the test site reaction;
• •2. Is using systemic/topical corticosteroids within 3 weeks prior to and/or during the study, or systemic/topical antihistamines 72 hours prior to and during the study;
• •3. Is not willing to refrain from using systemic/topical anti-inflammatory analgesics such as aspirin (81 mg daily aspirin will be allowed), Aleve, Motrin, Advil, or Nuprin for 72 hours prior to and during the study (occasional use of acetaminophen will be permitted);
• •4. Is using medication which, in the opinion of the Investigator, will interfere with the study results (e.g. anti-inflammatory medications, antipsychotics, anticonvulsants with potential pain relief effects, immunomodulatory medications, and others);
• •5. Is unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions or similar products on the back during the study;
• •6. Has psoriasis and/or active atopic dermatitis/eczema;
• •7. Has a known sensitivity or allergy to constituents of the materials being evaluated;
• •8. Is a female who is pregnant, plan to become pregnant during the study, or is breast feeding a child;
• •9. Has 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. Has received treatment for any type of internal cancer within 5 years prior to study entry;
• •11. Has a history of, or are currently being treated for skin cancer and/or hepatitis;
• •12. Has a history of, or is currently being treated for, insulin dependent diabetes;
• •13. Has any condition that might compromise study results;
• •14. Currently or expect to sunbathe or use tanning salons during the study;
• •15. Is currently participating in any clinical testing;
• •16. Has any known sensitivity to adhesives; and/or
• •17. Has received any investigational drug(s) within 4 weeks prior to study entry.