Photodynamic Therapy and Microvesicles

Early Phase 1WithdrawnNCT03960125

Wright State University

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Conditions

Photodynamic Therapy Microvesicle Particle

Interventions

Photodynamic TherapyDEVICE

Blue Light Therapy Exposure

4% ImipramineDRUG

A tricyclic antidepressant (TCA) medication. Though it is usually taken orally, topical preparations (4%) has use in topical anesthetics and anti-pain medicaments.

Base CreamDRUG

Control to 4% Imipramine

Eligibility

Sex: ALLMin age: 21 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Wright State Physicians

Fairborn, Ohio, United States

Outcomes

Primary Outcomes

Change in Microvesicle Particle Levels From Baseline with Photodynamic Therapy.

PI will assess change from baseline using three 5 mm punch biopsies.

Time frame: 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.

Time frame: Day 2

Secondary Outcomes

Change in Erythema From Baseline Due to Photodynamic Therapy

PI will assess change from baseline by using a non-invasive mexameter.

Time frame: 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)

Time frame: 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)

Time frame: Day 2

Data from ClinicalTrials.gov

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