Photodynamic Therapy and Microvesicles

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.

Study Overview

• Status: Withdrawn
• Conditions: Photodynamic Therapy; Microvesicle Particle
• Intervention / Treatment: Device: Photodynamic Therapy; Drug: 4% Imipramine; Drug: Base Cream

• Study Type: Interventional
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Fairborn, Ohio, United States, 45324
      • Wright State Physicians

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 4% Imipramine Cream on Upper Forearm Site; Base cream will be applied to the lower forearm site.	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.; Drug: Base Cream; Control to 4% Imipramine
Experimental: 4% Imipramine Cream on Lower Forearm Site; Base cream will be applied to the upper forearm site.	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.; Drug: Base Cream; Control to 4% Imipramine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Microvesicle Particle Levels From Baseline with Photodynamic Therapy.	PI will assess change from baseline using three 5 mm punch biopsies.	Day 0
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Erythema From Baseline Due to Photodynamic Therapy	PI will assess change from baseline by using a non-invasive mexameter.	Day 2
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
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

Collaborators and Investigators

• Sponsor: Wright State University
• Investigators: Principal Investigator: Jeffrey B Travers, MD, PhD, Wright State Physicians

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2021
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: May 20, 2019
• First Submitted That Met QC Criteria: May 20, 2019
• First Posted (Actual): May 22, 2019

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 7, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Antidepressive Agents, Tricyclic; Adrenergic Uptake Inhibitors; Imipramine
• Other Study ID Numbers: 06714

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes