Naloxone Hydrochloride Study for Relief of Pruritus in Patients With MF or SS Forms of CTCL
Status:
Recruiting
Trial end date:
2023-08-01
Target enrollment:
Participant gender:
Summary
This multi-center, double-blind, vehicle-controlled, randomized crossover design study will
evaluate the safety and efficacy of topically applied naloxone lotion, 0.5%, for the
treatment of pruritus in patients with the mycosis fungoides (MF) or Sézary syndrome (SS)
Forms of Cutaneous T-cell Lymphoma (CTCL). This study will also determine if there is
systemic absorption of the drug in a subset of subjects and if so, describe the range and
mean plasma levels reached after two weeks of three time daily (TID) dosing.
Funding Source - FDA OOPD