Photodynamic Therapy and Microvesicles

NCT03960125 | Withdrawn Early Phase 1 FDA Drug FDA Device

• 1 other identifier: 06714
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change in Erythema From Baseline Due to Photodynamic Therapy

  Day 2

• Change in Skin Pain From Baseline Due to Photodynamic Therapy

  Day 2

• Change in Itch From Baseline Due to Photodynamic Therapy

  Day 2

Study Arms (2)

4% Imipramine Cream on Upper Forearm Site

EXPERIMENTAL

Base cream will be applied to the lower forearm site.

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

4% Imipramine Cream on Lower Forearm Site

EXPERIMENTAL

Base cream will be applied to the upper forearm site.

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

Interventions

Photodynamic Therapy DEVICE

Blue Light Therapy Exposure

4% Imipramine Cream on Lower Forearm Site; 4% Imipramine Cream on Upper Forearm Site

4% Imipramine DRUG

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

4% Imipramine Cream on Lower Forearm Site; 4% Imipramine Cream on Upper Forearm Site

Base Cream DRUG

Control to 4% Imipramine

4% Imipramine Cream on Lower Forearm Site; 4% Imipramine Cream on Upper Forearm Site

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wright State University: lead

Study Sites (1)

Wright State Physicians

Fairborn, Ohio, 45324, United States

Location

MeSH Terms

Interventions

Photochemotherapy; Imipramine

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jeffrey B Travers, MD, PhD

  Wright State Physicians

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: May 22, 2019
• Study Start: March 29, 2021
• Primary Completion: August 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 13, 2022

Record last verified: 2022-09

Locations

US (1)