STUDY TO ASSESS THE LONG-TERM SAFETY OF EXTINA (KETOCONAZOLE) FOAM, 2%
Condition: Dermatitis, Seborrheic
MeSH terms: Dermatitis; Dermatitis, Seborrheic
Intervention: Ketoconazole
Intervention description: Foam, 2%, Extina will be applied twice daily (morning and evening) to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest. Study product should be applied at the first sign of a seborrheic dermatitis flare, and twice daily applications should continue until the area(s) has cleared. All symptom flares should be treated throughout the 12-month study period.
Intervention MeSH terms: Ketoconazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 498.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Phase 4; Seborrheic; Ketoconazole; Dermatitis

Summary:

      Extina (ketoconazole) Foam, 2% was approved for marketing in the United States (US) in June
      2007. Extina foam is indicated for topical treatment of seborrheic dermatitis in
      immunocompetent patients 12 years of age and older. The approved dosing regimen is twice
      daily for 4 weeks. The treatment of recurrent seborrheic dermatitis demands a topical
      preparation that is safe for both short-term and chronic application. This study is being
      conducted in order to obtain long-term safety data on the use of Extina (ketoconazole) Foam,
      2% in the treatment of seborrheic dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects must fulfill all of the following conditions or characteristics in order to be
        considered for study enrollment:

          1. 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.

          2. Male or female subjects 12 years of age or older.

          3. Able to complete the study and to comply with study instructions.

          4. 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.

          5. Seborrheic dermatitis on the face, scalp, ears, neck, or chest with an ISGA of 2, 3,
             or 4 at baseline

          6. 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:

          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.

         14. Only one subject per household may be entered into the study. These inclusion and
             exclusion criteria will be strictly adhered to throughout the study.