Photodynamic Therapy-Induced Immune Modulation: Part III
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
This study is designed as a double-blinded proof of concept of feasibility study to define if
the immunosuppression associated with photodynamic therapy (PDT) can be blocked by treatment
with cyclo-oxygenase-2 (COX-2) inhibitor celecoxib in comparison to placebo. PDT consists of
application of the photosensitizer 5-aminolevulinic acid followed by treatment with a blue
light. PDT is used to treat pre-cancerous actinic keratosis on large areas of skin. These
studies are a continuation of ongoing studies that indicate that the lipid mediator
platelet-activating factor (PAF) is generated in skin following PDT, and that PDT suppresses
the immune system. It is hypothesized that PDT-generated PAF results in the immunosuppression
associated with PDT. Therefore, it is proposed that a treatment to block that
immunosuppression could protect the patient undergoing PDT. Blockers of the PAF system are
not currently commercially available. However research studies done at Wright State
University using mice indicate that PAF- and PDT-induced immunosuppression is blocked by
treatment with COX-2 inhibitors. This study is conducted as a proof of concept.
Study length and visit for subjects with actinic keratoses: The first part of the study is
completed in 12 days then there are follow up visits at 6 and 12 months. There are a total of
6 separate visits to the research office.
Study length and visit for control subjects: The study is completed in 10 days. There are a
total of 4 separate visits to the research office.