Safety and tolerability.
toxicity, mycosis fungoides, itch, pain
CUTANEOUS T CELL LYMPHOMA, MYCOSIS FUNGOIDES, MINOR, ADVERSE EFFECTS, ADVERSE REACTION
The dose of NM applied to each participant (approximately 0.033 g/application) is 200,000 times less than the total amount applied during an average mycosis fungoides cutaneous T cell lymphoma (MF-CTCL) treatment and was not expected to induce significant adverse reaction. PRO-Diary wristwatch results identified minor adverse effects of NM application, including mild itch, burning sensation, pain, irritation, and warmth at the application site. No adverse effects warranted participant withdrawal or exclusion from the study; however, 1 participant from both the VitD(+) and the VitD(–) groups developed bullae in the investigative phase.VitD intervention was well tolerated with no adverse effects. Serum VitD-metabolite levels remained under the level of potential toxicity. For VitD(+) participants, the average serum 25(OH)D