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Brief Title: Naloxone Hydrochloride Study for Relief of Pruritus in Patients With MF or SS Forms of CTCL
Official Title: A Double Blind Randomized Vehicle Controlled Crossover Study to Evaluate the Safety and Efficacy of Topical Naloxone Hydrochloride Lotion 0.5% for the Relief of Pruritus in Patients With the MF or SS Forms of Cutaneous T-Cell Lymphoma
Study ID: NCT02811783
Brief 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
Detailed Description: There will be 160 subjects enrolled in the study. The study consists of a Screening Period of up to 7 days during which inclusion / exclusion criteria will be reviewed. Subjects meeting inclusion / exclusion criteria including the diagnostic criteria for MF or SS and a score of at least 5 on the 11-Point Numeric Rating Scale (NRS) for Pruritus will complete the one week Screening Period. Subjects will complete a daily diary for NRS for Pruritus scores and Sleep scores. At the end of the Screening Period, subjects who have a NRS for Pruritus score of at least 5 recorded in the diary on at least 4 of the 7 days preceding Day 0 will be eligible to continue. Baseline assessments will be recorded for vital signs, pruritic body surface area, skin integrity, PQOL, and laboratory results. The Baseline period will be followed by a 2 week Treatment Period 1 in which subjects will be randomized to Naloxone Lotion 0.5% or Placebo Lotion to be applied TID for 14 days. During the 2 week Treatment Period subjects will complete daily diaries of NRS for Pruritis scores and Sleep scores. On Day 14 subjects will return to the clinic to review diaries, adverse events (AEs), concomitant medications, and to record body surface area for pruritus, skin integrity, PQOL, and laboratory results. Subjects will then enter a Washout Period for up to 56 days until the subject again scores at least 5 on the NRS for Pruritus on 4 consecutive or 4 of the past 7 days or 56 days pass. Subjects will then enter a 2 week Treatment Period 2 during which the same procedures as Treatment Period 1 will be performed except subjects will receive the alternate treatment to that assigned in Treatment Period 1. Subjects will then have the option to enter a 26 Week Open Label Treatment Period 3 during which the same procedures as Treatment Period 1 and 2 will be performed except subjects will return only at Week 13 and Week 26 and all subjects will be treated with Naloxone Lotion 0.5%.
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
City of Hope, Duarte, California, United States
Stanford University, Palo Alto, California, United States
USSF Health Morsani Center for Advanced Healthcare, Tampa, Florida, United States
Cleveland Clinic Indian River Hospital, Vero Beach, Florida, United States
Robert H. Lurie Comprehensive Cancer Center, Chicago, Illinois, United States
Rush University Medical Center, Chicago, Illinois, United States
Dawes Fretzin Clinical Research Group, LLC, Indianapolis, Indiana, United States
University of Minnesota, Minneapolis, Minnesota, United States
St. Louis University Dermatology, Saint Louis, Missouri, United States
Washington University School of Medicine St. Louis, Saint Louis, Missouri, United States
Stony Brook Dermatology, Stony Brook, New York, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Inova Schar Cancer Institute, Fairfax, Virginia, United States
University of Washington / Seattle Cancer Care Alliance (SCCA), Seattle, Washington, United States
Name: Scott B Phillips, MD
Affiliation: Elorac, Inc.
Role: STUDY_DIRECTOR