Photodynamic Therapy and Microvesicles
Withdrawn before enrolling · Early Phase 1
Conditions studied: Photodynamic Therapy, Microvesicle Particle
In brief
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.
Key facts
- Study ID
- NCT03960125
- Run by
- Wright State University
- People needed
- 0
- Starts
- 2021-03-29
- Expected to finish
- 2022-09-01
- Last updated by the study team
- 2022-09-13
Who can join
Age: 21 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male adult subjects age 21 to age 45
- Skin type must be "fair", Fitzpatrick type I or II
- Able to understand/complete informed/consent
- Have access to stable transportation
You may not qualify if…
- Underlying diseases that could affect wound healing (e.g., diabetes mellitus)
- Taking medications that are known photosensitizers (e.g., doxycycline) or anti- inflammatories (e.g., NSAIDS [except for low-dose aspirin] or steroids)
- Have a history of abnormal scarring (e.g., keloids)
- Taking vitamin C or E supplements for past month
- Utilizing imipramine or any other tricyclic antidepressant (oral or cream)
- Utilizing topical anti-inflammatory or systemic agents (eg, prednisone)
- Tanning bed use within last 3 months
- PDT or UVB treatments in past 3 months
Where it is running
- Wright State Physicians — Fairborn, Ohio, United States
Full record on ClinicalTrials.gov
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