Ignite Creation Date:
2024-05-06 @ 1:12 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03960125
Status:
WITHDRAWN
Last Update Posted:
2022-09-13
First Post:
2019-05-20
Brief Title:
Photodynamic Therapy and Microvesicles
Sponsor:
Wright State University
Organization:
Wright State University
Study Overview
Official Title:
Photodynamic Therapy and Microvesicles
Status:
WITHDRAWN
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The PI decided to move in another direction with his research
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 PIs 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None