Photodynamic Therapy and Microvesicles

Photodynamic Therapy Clinical Trial

Official title:

Photodynamic Therapy and Microvesicles

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03960125
• Other study ID #: 06714
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: March 29, 2021
• Est. completion date: September 2022

Study information

• Verified date: September 2022
• Source: Wright State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Microvesicle Particle
• Photodynamic Therapy

Intervention

Device:
• Photodynamic Therapy
Blue Light Therapy Exposure

Drug:
• 4% Imipramine
A tricyclic antidepressant (TCA) medication. Though it is usually taken orally, topical preparations (4%) has use in topical anesthetics and anti-pain medicaments.
• Base Cream
Control to 4% Imipramine

Locations

Country	Name	City	State
United States	Wright State Physicians	Fairborn	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Wright State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Microvesicle Particle Levels From Baseline with Photodynamic Therapy.	PI will assess change from baseline using three 5 mm punch biopsies.	Day 0
Primary	Change in Microvesicle Particle Levels From Baseline with 4% Imipramine Cream Treatment.	PI will assess change from baseline using three 5 mm punch biopsies.	Day 2
Secondary	Change in Erythema From Baseline Due to Photodynamic Therapy	PI will assess change from baseline by using a non-invasive mexameter.	Day 2
Secondary	Change in Skin Pain From Baseline Due to Photodynamic Therapy	PI will assess change with the Skin Pain Visual Analogue Scale. Participants indicate the overall severity of skin pain from the photodynamic therapy treatment at the present time by placing a single mark on the horizontal scale (0 = no skin pain to 10 = severe skin pain)	Day 2
Secondary	Change in Itch From Baseline Due to Photodynamic Therapy	PI will assess change with the Itch Numerical Scale. Participants will rate itching severity due to photodynamic therapy treatment by circling the number that best describes the worst level of itching in the past 24 hours. (0 = No itch to 10 = Worst itch imaginable)	Day 2