Photodynamic Therapy and Microvesicles

Wright State University

Status and phase: Withdrawn; Early Phase 1

Conditions: Photodynamic Therapy; Microvesicle Particle

Treatments: Device: Photodynamic Therapy; Drug: 4% Imipramine; Drug: Base Cream

Study type: Interventional

Funder types: Other

Identifiers

NCT03960125

06714

Details and patient eligibility

About

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.

Sex: All

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

4% Imipramine Cream on Upper Forearm Site

Experimental group

Description:

Base cream will be applied to the lower forearm site.

Treatment:

Drug: Base Cream

Drug: 4% Imipramine

Device: Photodynamic Therapy

4% Imipramine Cream on Lower Forearm Site

Experimental group

Description:

Base cream will be applied to the upper forearm site.

Treatment:

Drug: Base Cream

Drug: 4% Imipramine

Device: Photodynamic Therapy