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

Inclusion Criteria

Subjects must fulfill all of the following conditions or characteristics in order to be considered for study enrollment:

• Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol-specific procedures are performed. For subjects between the ages of 12 and 17 years, a parent or legal guardian must be capable of understanding and willing to sign informed consent and subject must be capable of understanding and willing to sign an adolescent assent.
• Male or female subjects 12 years of age or older.
• Able to complete the study and to comply with study instructions.
• Female subjects of childbearing potential must have a negative pregnancy test. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception (which includes oral contraception, injectable or implantable methods, or intrauterine devices). Barrier methods of contraception are not acceptable. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. Abstinence is considered an appropriate barrier control method.
• Seborrheic dermatitis on the face, scalp, ears, neck, or chest with an ISGA of 2, 3, or 4 at baseline
• Subjects must have a discrete, evaluable target area of at least 0.5 cm2, with a score of 2, 3, or 4 for erythema and scaling on the Seborrheic Dermatitis Grading Scale

Exclusion Criteria

Subjects with any of the following conditions or characteristics will be excluded from study enrollment:

• Use of systemic antifungal agents, corticosteroids or other immunosuppressive therapies, or systemic retinoids within 4 weeks prior to the baseline visit.
• 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.
• 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.
• History of known or suspected intolerance to any of the ingredients of the study product.
• Female subjects who are pregnant, trying to become pregnant, or lactating.
• Any clinically relevant abnormal vital signs or findings on the physical examination.
• A clinically relevant history of abuse of alcohol or other drugs.
• Any major illness within 30 days prior to the baseline visit.
• Subjects with any clinically significant condition which would, in the opinion of the investigator, compromise the subject's participation in the study.
• Subjects who are immunocompromised.
• Considered unable or unlikely to attend the necessary visits.
• 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.
• 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.
• Only one subject per household may be entered into the study. These inclusion and exclusion criteria will be strictly adhered to throughout the study.