drugset / Trial / NCT03960125

Photodynamic Therapy and Microvesicles

NCT03960125

Phase 0 Withdrawn Wright State University
RandomizedParallel-groupDouble-blindBasic science

Summary

This study is designed to test whether localized photodynamic therapy (PDT) treatment will result in increased skin levels of microvesicle particle (MVP) and if the use of imipramine will counteract PDT generated MVP release. The effects of PDT and ultraviolet B radiation (UVB) on platelet-activating factor (PAF) and MVP production have long been part of the PI's research experience. To test this, the investigator plans to enroll up to enroll up to 12 male subjects whom are aged 21 to age 45. These subjects will be treated with topical 5-aminolevulinic acid gel (Ameluz) to small areas of forearm followed by treatment with blue light. The areas will then be treated with either 4% imipramine cream or cream base as control. Four hours later, the redness of the areas will be measured using a mexameter and MVPs measured in skin biopsies taken from PDT-treated skin.

Timeline

Start
2021-03-29
Primary completion
2022-08
Completion
2022-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Imipramine Small molecule 4 % Topical

Indications

No indication recorded.