Official Title: “A Phase 4, Open-Label Study to Assess the Long-Term Safety of Extina (Ketoconazole) Foam, 2% in the Treatment of Seborrheic Dermatitis.”

Open-label, multicenter, single-group study to assess the long-term safety of twice daily treatment with Extina (ketoconazole) Foam, 2% in subjects with seborrheic dermatitis.

Study Type: Interventional

Study Design: Treatment, Open Label, Single Group Assignment, Safety Study

Study Primary Completion Date: June 2010

The study subjects must have seborrheic dermatitis and will apply Extina (ketoconazole) Foam, 2% topically twice a day (morning and evening) to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until resolution throughout the 12 month study period.

Study visits will occur at baseline (day 1) and at weeks 4, 8, 16, 26, 39, and 52 (or early withdrawal). Safety will be assessed by evaluation of adverse events (AEs), vital signs, physical examinations, withdrawals from the study, and results of safety laboratory tests.

Intervention(s) in this Clinical Trial

• Drug: Extina (ketoconazole) foam, 2%
  • All subjects will apply Extina (ketoconazole) Foam, 2% topically twice a day (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.

Arms, Groups and Cohorts in this Clinical Trial

• Other: Open Label
  • Open Label

Primary Measures

• To assess the long-term safety of Extina (ketoconazole) Foam, 2% in the treatment of seborrheic dermatitis.
  • Time Frame: 1 year
    Safety Issue?: No

Inclusion Criteria:

• 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 agree to use a medically acceptable form of contraception .
• Seborrheic dermatitis on the face, scalp, ears, neck, or chest

Exclusion Criteria:

• 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 4 weeks prior to the baseline visit, or subjects 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 or clinically significant condition which would, in the opinion of the investigator, compromise the subject's participation in the study.
• Considered unable or unlikely to attend the necessary visits.
• Currently using any medication, which in the opinion of the investigator may affect the evaluation of the study product or place the subjects at undue risk.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Stiefel Laboratories

Overall Clinical Trial Officials and Contacts

David A Angulo, MD Study Director Stiefel Labortories, Inc., Sr. Director Global Clinical Research  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00703846

Study ID Number: U0275-01

ClinicalTrials.gov Identifier: NCT00703846

Health Authority: United States: Food and Drug Administration