Conditions: Seborrheic Dermatitis
Keywords: dandruff, flaky scalp
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 23
Healthy volunteers: yes

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo. arm 2: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks. arm 3: apply ketoconazole 2% foam to scalp twice daily for four weeks. 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 using shampoo.

Interventions: intervention 1: ketoconazole 2% foam intervention 2: ketoconazole 2% shampoo
Intervention descriptions: intervention 1: Subjects in the Foam (F) group will apply ketoconazole 2% foam to the scalp twice daily for four weeks. intervention 2: Subjects in the Shampoo (S) group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.

Protocol document: