NCT02448381.

Study name	A phase 3 multicenter, randomised, double‐blind, placebo controlled study to determine the efficacy of topical SGX301 (synthetic hypericin) and fluorescent Bulb‐Light Irradiation for the treatment of cutaneous T‐cell lymphoma
Methods	This study is a randomised, controlled trial comparing topical SGC301, a topical photosensitising agent, vs. placebo to treat patients with patch/plaque phase cutaneous T‐cell lymphoma (mycosis fungoides)
Participants	Inclusion criteria Participants must have a clinical diagnosis of cutaneous T‐cell lymphoma (CTCL) (mycosis fungoides (MF)), Stage IA, Stage IB, or Stage IIA Participants must have a minimum of three (3) evaluable, discrete lesions Participants must be willing to refrain from sunbathing for the duration of the study Exclusion criteria History of sun hypersensitivity and photosensitive dermatoses including porphyria, systemic lupus erythematosus, Sjögren's syndrome, xeroderma pigmentosum, polymorphous light eruptions or radiation therapy within 30 days of enrolling Participants receiving topical steroids or other topical treatments for CTCL within 2 weeks Participants receiving systemic steroids, nitrogen mustard, psoralen UVA radiation therapy (PUVA), narrow band UVB light therapy (NB‐UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 3 weeks of enrolment
Interventions	Arm I Three treatment cycles, each six weeks followed by a two‐week rest period. Treatment uses 0.25% SGX301 in USP Hydrophilic Ointment (or placebo) applied twice per week followed by fluorescent light therapy Cycle 1: patients randomised 2:1 to active/placebo will have three index lesions treated and evaluated Cycle 2: all patients will have three index lesions treated and evaluated with active SGX301 ointment Cycle 3: all patients will be given the opportunity to enter an open‐label cycle of active SGX301 ointment treatment for all lesions (index and non‐index) Arm II Placebo ointment is indistinguishable from ointment containing active SGX301 and is only used in Cycle 1. Treatment paradigm (ointment application and fluorescent light therapy) is identical USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12‐24 hours, then treated with an initial dose of 5 J/cm² fluorescent light
Outcomes	Primary outcomes of the trial Treatment response in 3 treated lesions as defined as a ≥ 50% improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) score when compared to patients receiving placebo To evaluate the ability of a 6‐week course of SGX301 and visible light in patients with patch/plaque phase cutaneous T‐cell lymphoma (CTCL, MF) to induce a treatment response in 3 lesions when compared to patients receiving placebo and visible light Secondary outcomes of the trial Complete response in 3 treated lesions as defined to be a CAILS score of 0 To evaluate the ability of topical SGX301 and visible light in patients with patch/plaque phase CTCL to induce biopsy‐proven complete response Degree of improvement of 3 treated lesions as measured by the CAILS score To evaluate the degree of improvement of the lesions induced by topical SGX301 and visible light in patients with patch/plaque phase CTCL Duration of response as measured monthly for 6 months by the appearance of new lesions after the treatment period has ended To evaluate the duration of partial and/or complete response in the lesions induced by topical SGX301 and visible light in patients with patch/plaque phase CTCL Time to relapse as measured by any disease recurrence in participants with a complete response To evaluate the time to lesion relapse induced by topical SGX301 and visible light in patients with patch/plaque phase CTCL. Safety as assessed by the number of participants with adverse events To assess the safety of topical SGX301 and visible light in patients with patch/plaque phase CTCL.
Starting date	December 2015
Contact information	Sponsors and collaborators Soligenix
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