NCT03292406.

Study name	A safety, efficacy and pharmacokinetics study of CD11301 for the treatment of Cutaneous T‐Cell Lymphoma (CTCL)
Methods	This is a randomised, controlled trial comparing topical treatment with CD11301 or placebo in patients with mycosis fungoides
Participants	Inclusion Criteria Age >18 Clinical Diagnosis of CTCL stage IA, IB, or IIA with biopsy within last 3 months Have body surface area involvement corresponding to stages IA, IB or IIA CTCL with at least 3 distinct lesions Exclusion Criteria CTCL that is stage IIB or great or stage IIA with stage N2 with >5% circulating Sezary cells or CD8+ or large cell transformation or Progressive CTCL
Interventions	Arm I Placebo followed by CD11301 (0.03%) Topical Gel Arm II CD11301 (0.03%) Topical Gel Arm III CD11301 (0.06%) Topical Gel
Outcomes	Primary outcomes of the study Overall response rate (complete and partial response) of target lesions at week 12 based on the Composite Assessment of Index Lesion Severity (CAILS) score Secondary outcomes of the study Overall response rate based upon mSWAT composite score at Week 12
Starting date	December 2017
Contact information	Sponsors and Collaborators Galderma R&D Investigators Galderma R&D
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