NCT02213861.

Study name	A randomized phase 2 study to evaluate three treatment regimens of SHAPE, a histone deacetylase inhibitor, in patients with stage IA, IB or IIA cutaneous T‐cell lymphoma
Methods	This is a randomised, controlled trial comparing three treatment regimens of SHAPE, a histone deacetylase inhibitor, in patients with mycosis fungoides
Participants	Inclusion criteria Histological confirmation of cutaneous T‐cell lymphoma (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 Exclusion criteria CTCL with histological 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) CTCL disease that is known to be refractory to systemic histone deacetylase inhibitors
Interventions	Arm I 1.0% SHAPE Gelled Solution once daily Arm II 0.5% SHAPE Gelled Solution twice daily Arm III 1.0% SHAPE Gelled Solution twice daily
Outcomes	Primary outcome of the trial Lesion severity using CAILS (Composite Assessment of Index Lesion Severity) Secondary outcomes of the trial Modified Severity Weighted Assessment Tool (mSWAT) Patient assessment of pruritis using a Visual Analogue Scale (VAS) Skindex‐29 Quality of Life tool Modified Composite Assessment of Index Lesion Severity (CAILS)
Starting date	November 2014
Contact information	Sponsors and collaborators TetraLogic Pharmaceuticals
Notes	‐