EL-1007-01-01: 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)
Sponsor: |
Elorac, Inc. |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAQ8604 |
U.S. Govt. ID: |
NCT02811783 |
Contact: |
Grace Ulerio: 212-305-8444 / gu2102@cumc.columbia.edu |
You are being asked to participate in a research study because you have Cutaneous T-Cell Lymphoma/Mycosis Fungoides, and one of your symptoms is itching. 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) that involves abnormal white blood cells in the blood and skin. Naloxone is a drug that is approved for use given directly into the blood stream for the treatment of narcotic overdose by blocking their effects. The Vehicle Lotion is the same lotion as the Naloxone Lotion, but it does not contain the active ingredient, Naloxone. This study will also determine if there is absorption of the drug into the blood in some subjects at some study sites.
This study is closed
Investigator
Larisa Geskin, MD
Are you at least 21 years of age? |
Yes |
No |
Have you been diagnosed with Cutaneous T-Cell Lymphoma/Mycosis Fungoides ? |
Yes |
No |