A DOUBLE BLIND RANDOMIZED VEHICLE CONTROLLED CROSSOVER STUDY

Recruiting

99 years or below

All

Phase 3

10 participants needed

1 Location

Brief description of study

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) .

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions: ['Mycosis Fungoides', 'Lymphoma, T-Cell, Cutaneous', 'Sézary Syndrome']
Age: 99 years or below
Gender: All

Updated on 19 Feb 2024. Study ID: 825746

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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

Brief description of study

Eligibility of study

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