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: 2123056953 / gu2102@cumc.columbia.edu |
This is a phase 2 study to determine the efficacy and safety of Naloxone HCL Lotion 0.5% for the treatment of mycosis fungoides (MF) type of cutaneous T-cell lymphoma (CTCL). Selected subjects will have the study drug applied to determine its effect on reducing itchiness and any potential side effects. Naloxone has previously been approved for direct blood administration for the treatment of narcotic overdose and has potential to treat the itchiness associated with MF. This is a 5 visit 6-9 week study involving blood collections and skin examinations performed in the clinic.
This study is closed
Investigator
Larisa Geskin, MD
Do you have mycosis fungoides (MF)? |
Yes |
No |
Have you been experiencing daily ichiness for more than a month? |
Yes |
No |
Can you follow treatment instructions and visits? |
Yes |
No |
(Females only) Are you pregnant or nursing? |
Yes |
No |