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



Status:Completed
Conditions:Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 89
Updated:10/14/2017
Start Date:September 2010
End Date:June 2013

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Seborrheic Dermatitis of the Scalp in Populations Practicing Less Frequent Hair Washing: Ketoconazole 2% Foam Versus Ketoconazole 2% Shampoo

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.

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
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