Efficacy, Safety and Tolerability Study of SHAPE in IA, IB or IIA Cutaneous T-cell Lymphoma

Inclusion Criteria:

   - Histological confirmation of CTCL; a documented verifiable biopsy report is required

   - Documented clinical stage IA, IB or IIA CTCL

   - Skin lesion involvement of at least 2% of BSA accessible for topical application of
   study drug

   - ECOG performance status of 0-2

Exclusion Criteria:

   - CTCL with histologic evidence of folliculotropic variant or large cell transformed
   CTCL

   - Palpable lymph node ≥1.5 cm in diameter (unless the lymph node has been biopsied and
   designated as Stage IA-IIA disease)

   - Co-existent second malignancy or history of prior solid organ malignancy within
   previous 5 years (excluding basal or squamous cell carcinoma, in situ carcinoma of the
   cervix (CIN3), papillary or follicular thyroid cancer or prostate cancer that has been
   treated curatively

   - Any prior history of hematologic malignancy (other than CTCL) within past 5 years

   - CTCL disease that is known to be refractory to systemic histone deacetylase inhibitors

   - Prior or concurrent central nervous system (CNS) metastases

   - History of or current major gastrointestinal, pulmonary, cardiovascular, genitourinary
   or hematologic disease, CNS disorders, infectious disease or coagulation disorders as
   determined by the Investigator

   - Evidence of active Hepatitis B or C or HIV

   - Circulating atypical cells of clinical significance