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

Inclusion criteria

• ✓. Signed informed consent has been obtained.
• ✓. Subject is at least 21 years of age.
• ✓. Diagnosis of mycosis fungoides (MF) or Sézary syndrome (SS) will be based on a combination of histological, clinical, and immunophenotypical criteria. The histological criteria will be based on skin biopsy from the most representative skin area. The diagnostic criteria used for each subject will be specified in the case report forms and the specific classification of MF or SS will be identified. The TNMB system will be used to classify the stage of disease (See Section 8.4 for details).
• ✓. Completion of the mSWAT assessment.
• ✓. A history of pruritus that meets following criteria:
• ✓. Pruritic treatment area of 5-95% of the subject's total treatable body surface area.
• ✓. Subject can be expected to reliably follow treatment instructions and visit schedule.
• ✓. Non-pregnant, non-lactating females of childbearing potential who agree to use medically acceptable forms of birth control (abstinence, hormonal contraceptives, diaphragm with spermicide, condom with spermicide, or intrauterine device) throughout the study or females of non-childbearing potential (surgically sterile \[hysterectomy or bilateral tubal ligation\] or post-menopausal ≥ 1 year). A negative urine pregnancy test must be confirmed at Baseline screening for all female subjects who are not post-menopausal \> 1 year or surgically sterile.