Table 3.

Registered clinical trials on photodynamic therapy against cutaneous lymphomas.

NCT Number Year Start	Title	Intervention	Phases	Status	Results
NCT00023790 2003	Photodynamic Therapy in Treating Patients with Skin Cancer or Solid Tumors Metastatic to the Skin	Silicon phthalocyanine 4 (Pc 4) over 2 h on Day 1, followed by light therapy over 30–60 min on Day 2. Treatments repeated 6 weeks for a total of 2 courses.	Phase 1	Terminated due to slow accrual	N/A
NCT00103246 8 February 2005	Photodynamic Therapy Using Silicon Phthalocyanine 4 in Treating Patients with Actinic Keratosis, Bowen’s Disease, Skin Cancer, or Stage I or Stage II Mycosis Fungoides	Participants receive topical silicon phthalocyanine 4 (Pc 4). One hour later, participants undergo photodynamic therapy. Treatment repeats weekly for up to 3 weeks (up to 3 total treatments for the same lesion OR up to 3 lesions treated if multiple lesions are present). Cohorts of 3 participants receive escalating doses of Pc 4 and visible light until the maximum tolerated dose (MTD) is determined.	Phase 1 44 cases were enrolled: MF 35 cases, actinic keratosis 4 cases, squamous cell carcinoma 2 cased, basal cell carcinoma, 2 cases	Completed August 2010	MF, 14/35 (40% with 95% CI: 0.26–0.56) responded [65]
NCT01800838 April 2013	Silicon Phthalocyanine 4 and Photodynamic Therapy in Stage IA-IIA Cutaneous T-Cell Non-Hodgkin Lymphoma	A dose-escalation study. Silicon Phthalocyanine 4 (Pc 4) PDT at 0.1–0.5 mg/mL with visible light at a wavelength of 675 nm at a fluence of 50–150 J/cm2.	Phase 1	Completed May 2015	All 11 patients completed the trial with no serious adverse events. The maximum tolerated dose (MTD) of PDT was 150 J/cm2, and the MTD of Pc 4 was 0.1 mg/mL.
NCT02448381 December 2015	FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)	SGX301 (synthetic hypericin)-PDT for early-stage (IA-IIA) MF/CLCT, twice weekly for 6 weeks.	Phase 3 Randomized, double-blind, placebo-controlled study	Completed November 2020	Hypericin PDT was more effective than placebo, index lesion response rate (ILRR), defined as 50% or greater improvement, after Cycle 1 of treatment (16% vs. 4%; p = 0.04) [67]
NCT03281811 13 November 2017	Photodynamic Therapy in Treating Patients with Refractory Mycosis Fungoides	Patients receive aminolevulinic acid hydrochloride topically and undergo photodynamic therapy on Day 1. Treatment repeats every 4 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning at Week 24, patients undergo radiation therapy daily for 4 weeks.	Early phase 1 11 cases with 30 lesions, single group assignment	Completed 12 August 2020	Response rates of 36.4% by Physician Global Assessment [64]
NCT05380635 9 May 2022	Pharmacokinetic (PK) and electrocardiogram (ECG) Determinations Following 8 Weeks of HyBryte Treatment for Cutaneous T-Cell Lymphoma	HyBryte (0.25% hypericin, SGX301) ointment was applied to CTCL lesions and treated with visible light 18–24 h later starting at 5 J/cm2. Treatment performed twice a week for 8 weeks	Phase 2 Single group assignment	Completed 16 August 2022	N/A