Clinical Trial

Naloxone Hydrochloride Study for Relief of Pruritus in Patients With MF or SS Forms of CTCL

Investigator
Complete title:
A Double Blind, Randomized, Vehicle Controlled, Crossover Study to Evalute the Safety and Efficacy of Topical Naloxone Hydrochloride Lotion, 0.5%, for the Relief of Pruritus in Patients with the Mycosis Fungoides (MF) or Sezary Syndrome (SS) Forms of Cutaneous T-Cell Lymphoma (CTCL)
Trial phase:
Phase III
Study ID:
NCT02811783
Local study ID:
20161793
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.
Trial keywords:
Hematologic Malignancies, Lymphoma, Lymphoproliferative Disorders, Lymphoma, Non-Hodgkin (NHL), Mycosis Fungoides/Sezary Syndrome, Immunoproliferative Disorders, Lymphoma, T-Cell, Lymphoma, T-Cell, Cutaneous, Immune System Diseases, Mycoses, Skin Diseases, Sezary Syndrome, Pruritus
Enrollment status:
Recruiting
Trial eligibility
** For Eligibility information, please click on the "LOOK UP TRIAL AT NIH" link above. **
Other eligibility criteria may apply.
Trial exclusions
Other exclusion criteria may apply.
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