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

NCT02811783 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2022-10-28

No results posted yet for this study

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

Conditions

  • Mycosis Fungoides
  • Lymphoma, T-Cell, Cutaneous
  • Sézary Syndrome

Interventions

DRUG

Naloxone Hydrochloride Lotion, 0.5%

Topical TID for 2 weeks

DRUG

Placebo Lotion

Topical TID for 2 weeks

Sponsors & Collaborators

  • Elorac, Inc.

    lead INDUSTRY

Principal Investigators

  • Scott B Phillips, MD · Elorac, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2022-09-30
Completion
2022-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02811783 on ClinicalTrials.gov