Phase I Photodynamic Therapy (PDT) for Benign Dermal Neurofibromas (NF1)
Status:
Completed
Trial end date:
2016-07-07
Target enrollment:
Participant gender:
Summary
GENERAL OBJECTIVE The general objective is to assess the safety and efficacy of photodynamic
therapy (PDT) in the treatment of neurofibromatosis 1 (NF1) tumors in the skin.
SPECIFIC OBJECTIVE This is a light dose escalation pilot study to determine the safety and
efficacy of PDT using 5-aminolevulinic acid (ALA) and 633 nm light in the treatment of benign
dermal neurofibromas.
Specifically, the primary goal of the current study is to determine the maximum tolerable
light doses that can be administered to subjects undergoing topical photoillumination
photodynamic therapy with standard application of Levulan Kerastick (ALA) for Topical
Solution.