NCT02301494.

Study name	Feasibility study to determine effectiveness of 3.75% topical imiquimod cream and topical Vanos (fluocinonide) cream 0.1% in the treatment of early stage cutaneous T‐cell lymphoma
Methods	This is a randomised, controlled trial comparing topical 3.75% Imiquimod cream vs. 0.1% Fluocinonide cream in patients with mycosis fungoides
Participants	Inclusion criteria Male and female participants aged ≥18 years Diagnosis of mycosis fungoides (MF) In cases with equivocal histological features, the diagnosis may be confirmed through the use of clonal T‐cell gamma gene rearrangement, as detected by polymerase chain reaction (PCR) amplification and primer sets specific for the T‐cell receptor gamma chain genes Participants must have at least one target lesion Eligible patients will be those who topical corticosteroid would be a preferred treatment and include patients newly diagnosed with stage IA, IB, or IIA disease, or those patients currently stable on therapy, in whom topical corticosteroids are being newly added to the regimen (i.e. recurrence or resistant lesions not currently treated with topical corticosteroids) Exclusion criteria Have any reason which, in the opinion of the investigator, interferes with the ability of the participant to participate in or complete the trial, or which places the participant at undue risk such as a history of drug, alcohol or other substance abuse or other factors limiting the ability to co‐operate and to comply with this protocol Lesions on the genitals, axillae and face will not be selected for study treatment and evaluation
Interventions	Arm I Fluocinonide (Vanos) cream 0.1% will be applied as currently approved by the FDA for treatment of corticosteroid responsive disorders of the skin. Treatment will continue for 4 months with a follow‐up at 6 and 12 months Arm II 3.75% imiquimod (Zyclara) Cream will be used as currently labelled by the FDA for treatment of actinic keratoses. Treatment will continue for 4 months with follow‐up at 6 and 12 months
Outcomes	Primary outcome of the trial Response rate between baseline and week 16 Treatment phase will last 4 months with follow‐up at 6 and 12 months after initiation of therapy Secondary outcomes of the trial Response Rate 24 and 52 weeks after baseline Patients will be treated for 4 months and response rate assessed at 6 and 24 months after initiation of therapy. Safety and tolerability of Imiquimod in patients with cutaneous T‐cell lymphoma (CTCL) (adverse events) Adverse events that occur during the course of the study Learn about T cell dysregulation in the skin from patients with CTCL (using left over tissue from biopsies) Using left over tissue from biopsies done at baseline, two weeks after initiation of therapy, and optional one done at week16. We are interested in making our tissue bank.
Starting date	November 2014
Contact information	Sponsors and Collaborators Rochester General Hospital, Valeant Pharmaceuticals International, Inc., Rochester Skin Lymphoma Medical Group, PLLC Investigators Principal Investigator: Brian Poligone, M.D. Ph.D., Rochester General Hospital
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