STUDY TO ASSESS THE LONG-TERM SAFETY OF EXTINA (KETOCONAZOLE) FOAM, 2%

Exclusion Criteria

• •Subjects with any of the following conditions or characteristics will be excluded from study enrollment:
• •1. Use of systemic antifungal agents, corticosteroids or other immunosuppressive therapies, or systemic retinoids within 4 weeks prior to the baseline visit.
• •2. Use of topical antifungal therapy, corticosteroid therapy, or calcineurin inhibitors to the face, scalp, ears, neck, or chest within 2 weeks prior to the baseline visit.
• •3. Use of any investigational drugs within 8 weeks prior to the baseline visit, or subjects who are scheduled to receive an investigative drug other than the study product during the period of the study.
• •4. History of known or suspected intolerance to any of the ingredients of the study product.
• •5. Female subjects who are pregnant, trying to become pregnant, or lactating.
• •6. Any clinically relevant abnormal vital signs or findings on the physical examination.
• •7. A clinically relevant history of abuse of alcohol or other drugs.
• •8. Any major illness within 30 days prior to the baseline visit.
• •9. Subjects with any clinically significant condition which would, in the opinion of the investigator, compromise the subject's participation in the study.
• •10. Subjects who are immunocompromised.
• •11. Considered unable or unlikely to attend the necessary visits.
• •12. Employees of Stiefel Laboratories or a contract research organization involved in the study, or an immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of an employee.
• •13. Currently using any medication, which in the opinion of the investigator may affect the evaluation of the study product or place the subject at undue risk.