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 MYCOSIS FUNGOIDES (MF) FORM OF CUTANEOUS T-CELL LYMPHOMA (CTCL

  • STATUS
    Recruiting
  • participants needed
    10
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Updated on 19 February 2024

Summary

This application is a request to execute a reliance agreement with Chesapeake an external IRB This study is being done to assess the efficacy and safety of Naloxone HCL Lotion 0.5% compared to Vehicle Lotion for the treatment of itching in patients with mycosis fungoides (MF), which is a type of cancer called cutaneous T cell lymphomas (CTCL). This is a topical treatment. The crossover treatment design entails an initial randomized assignment to either Naloxone Lotion or the Vehicle Lotion for a two-week period, and after a suitable washout period, an assignment to the alternative treatment for a second two-week period. Study participation involves four periods: a) Screening Period, b) Treatment Period 1, c) Washout Period, and d)Treatment Period 2. Subjects at least 21 years of age with a diagnosis of mycosis fungoides (MF) .

Details
Condition ['Mycosis Fungoides', 'Lymphoma, T-Cell, Cutaneous', 'Sézary Syndrome']
Age 99years or below
Clinical Study Identifier02811783
Last Modified on19 February 2024

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