Seborrheic Dermatitis: Ketoconazole 2% Foam Versus Ketoconazole 2% Shampoo

• Compliance [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
  Patient compliance will be evaluated by having patients keep a diary documenting the use of study drug. They will also be questioned about their medication usage at every visit. In addition, we will weigh the study drug at every visit.
• Patient Satisfaction [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
  Patient satisfaction will be measured using a five point satisfaction scale.
• Additional Improvement in the Total Dandruff Severity Score (TDSS) [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
  Shampoo subjects will be able to cross over into the foam group if their TDSS score does not improve by 60% at the end of the four week treatment period. These cross over subjects will remain in the study for an additional four weeks and apply foam in the same manner as subjects in the original foam group.

The aims of this study are to compare the effectiveness of antifungal foam versus antifungal shampoo and determine patient compliance and satisfaction with both vehicles among African American females with dandruff practicing less than once weekly hair washing.

A wide variety of topical vehicles are available for medications that treat scalp disorders. Proper vehicle selection is important when managing scalp conditions, such as seborrheic dermatitis, because the efficacy of these treatments depends largely on compliance and the amount of active ingredient delivered to the scalp. It is therefore important to prescribe vehicles that are easy to apply and cause the least amount of disruption to the patients' pre-existing hair care practices. One of the most common rate limiting hair care practices among different cultures is wash frequency. Literature shows African American women are more likely to wash their hair less than once weekly versus Caucasian women. We hypothesize certain vehicles, such as foam preparations which do not require hair washing, will be more efficacious in African American women with seborrheic dermatitis than shampoo preparations.

• Drug: ketoconazole 2% foam
  Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.
  Other Name: Extina
• Drug: ketoconazole 2% shampoo
  Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.
  Other Name: Nizoral

• Active Comparator: Shampoo Group
  Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.
  Intervention: Drug: ketoconazole 2% shampoo
• Active Comparator: Foam group
  Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.
  Intervention: Drug: ketoconazole 2% foam
• Active Comparator: Cross Over Group
  Subjects in the Shampoo group will be able to cross over into the Foam group if the TDSS score does not improve by 60% at the end of the four week treatment period. These cross over subjects will remain in the study for an additional four weeks and apply foam in the same manner as subjects in the original Foam group.
  Intervention: Drug: ketoconazole 2% foam

Inclusion Criteria:

• African American females aged 18 to 89 years
• Previous diagnosis of seborrheic dermatitis of the scalp
• TDSS between 50 and 200
• Practice less than or equal to once weekly hair washing
• Immunocompetent
• Willing to not grease or oil scalp

Exclusion Criteria:

• Age below 18 years or above 89 years
• Medical history of psoriasis, diabetes mellitus, immunosuppression, neurologic disorders, and/or chronic disease not stabilized by medication
• Patients taking any oral steroids and/or antifungals within 30 days of enrollment
• Sensitivity to any formulation components of either ketoconazole foam or shampoo including sulfur
• The use of any topical medications including over the counter products indicated for the treatment of seborrheic dermatitis within 14 days of enrollment
• Pregnant women, women who plan on becoming pregnant, or breastfeeding women
• Current use or history of using any biologic medication