NCT01203189

Trial name or title	Seborrheic Dermatitis: Ketoconazole 2% Foam Versus Ketoconazole 2% Shampoo
Methods	Individual randomised controlled trial
Participants	Diagnosis: seborrhoeic dermatitis of the scalp in African American females aged 18 to 89 years, with symptom score of 50 to 200, who are willing to not grease or oil scalp Exclusion criteria: age younger than 18 years or older than 89 years; history of psoriasis, diabetes mellitus, immunosuppression, neurological disorders or chronic disease not stabilised by medication; persons taking oral steroids and/or antifungals within 30 days before enrolment; sensitivity to any formulation of ketoconazole foam or shampoo or sulphur; use of any topical medications indicated for the treatment of seborrhoeic dermatitis within 14 days of enrolment; pregnant women or women who plan on becoming pregnant; breastfeeding women
Interventions	Intervention: ketoconazole 2% shampoo applied twice weekly to scalp for 4 weeks Control: ketoconazole 2% foam applied to the scalp twice daily for 4 weeks
Outcomes	Sympton severity score, compliance
Starting date	September 2010
Contact information	Jeaneen A Chappell, MD; jchappe1@slu.edu
Notes	Study is being conducted by Louis University Department of Dermatology, USA. Results have been requested but have not yet been received