Topical hypericin photodynamic therapy safe and effective against early-stage mycosis fungoides: JAMA

The major endpoint for cycle 1 was the index lesion response rate (ILRR), which was defined as a 50% or higher improvement in the modified Composite Assessment of Index Lesion Severity (mCAILS) score from baseline after 6 weeks of therapy. Open-label response rates were secondary end objectives in cycles 2 and 3. Adverse events (AEs) were recorded at each treatment visit, at the end of each cycle, and subsequently once a month for six months. On December 21, 2020, data analysis was carried out.

The highlights of this study were:

1. There were 169 patients with early-stage MF/CTCL in the study population where Hypericin PDT outperformed a placebo after six weeks of treatment.

2. After two cycles of hypericin PDT, the ILRR rose to 40% in the patients, and after three cycles, it rose to 49%.

3. In both patch and plaque type lesions, significant clinical improvements were seen, and they were consistent regardless of age, sex, race, stage IA vs. IB, time since diagnosis, and the number of prior therapies.

4. Mild local skin and application-site responses were the most frequent AEs associated with therapy, but there were no major adverse medication reactions.

The researchers conclude," topical synthetic hypericin activated with visible light is an effective and well-tolerated PDT for early-stage MF/CTCL." 

Reference:

Kim, E. J., Mangold, A. R., DeSimone, J. A., Wong, H. K., Seminario-Vidal, L., Guitart, J., Appel, J., Geskin, L., Lain, E., Korman, N. J., Zeitouni, N., Nikbakht, N., … Poligone, B. (2022). Efficacy and Safety of Topical Hypericin Photodynamic Therapy for Early-Stage Cutaneous T-Cell Lymphoma (Mycosis Fungoides). In JAMA Dermatology. American Medical Association (AMA). https://doi.org/10.1001/jamadermatol.2022.2749