The study is conducted in two parallel arms with active control to assess the efficacy, safety and tolerability of the investigational treatment. It is planned to randomize up to 300 patients. Ten investigative sites will be enrolling patients. The total duration of subject participation in the study will be slightly more than one month.
Seborrheic dermatitis is an inflammatory disease affecting areas of the scalp and trunk where sebaceous glands are most prominent. This disease is caused by yeast-like fungi. To date, a large number of patients do not respond to shampoos available at the market and may need another more effective treatment. The investigational product is expected to reduce the frequency of disease relapse.
In this project, OCT is responsible for all study plans, selection and initiation visits, management and monitoring of investigative sites, project management, as well as interaction with ethical committees, pharmacovigilance and logistics. All data management activities will be performed by Data MATRIX.