Clinical Trial Detail

Clinical Trials

Clinical Trial Detail

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

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)

Research Study Number 20161793
Principal Investigator Michi Shinohara
Phase II/III

Research Study Description

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.

Eligibility Criteria (must meet the following to participate in this study)

** For Eligibility information, please click on the "LOOK UP TRIAL AT NIH" link above. **

Other eligibility criteria may apply.

Research Study Number 20161793
Contact Niall Curley
Telephone 206/606-1231

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

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