Photodynamic Therapy and Microvesicles

NCT ID: NCT03960125

Last Updated: 2022-09-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-29
• Study Completion Date: 2022-09-30

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 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.

Conditions

Photodynamic Therapy; Microvesicle Particle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

4% Imipramine Cream on Upper Forearm Site

Base cream will be applied to the lower forearm site.

Group Type: EXPERIMENTAL

Photodynamic Therapy

Intervention Type: DEVICE

Blue Light Therapy Exposure

4% Imipramine

Intervention Type: DRUG

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

Intervention Type: DRUG

Control to 4% Imipramine

4% Imipramine Cream on Lower Forearm Site

Base cream will be applied to the upper forearm site.

Group Type: EXPERIMENTAL

Photodynamic Therapy

Intervention Type: DEVICE

Blue Light Therapy Exposure

4% Imipramine

Intervention Type: DRUG

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

Intervention Type: DRUG

Control to 4% Imipramine

Interventions

Photodynamic Therapy

Blue Light Therapy Exposure

Intervention Type: DEVICE

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.

Intervention Type: DRUG

Base Cream

Control to 4% Imipramine

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wright State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey B Travers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wright State Physicians

Locations

Wright State Physicians

Fairborn, Ohio, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

06714

Identifier Type: -

Identifier Source: org_study_id