Phase II Double-Blind, Placebo-Controlled Study of the Safety and Preliminary Effectiveness of MTS-01 for the Prevention of Alopecia Induced by Whole Brain Radiotherapy
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Effectiveness will be based on a comparison of hair retention scores between MTS-01 and placebo.
Assessments occur weekly during treatment and follow-up assessments occur for 12 weeks following treatment.
James Metz, MD
University of Pennsylvania
United States: Food and Drug Administration
|University of Arizona||Tucson, Arizona 85724|
|University of Pennsylvania||Philadelphia, Pennsylvania 19104|