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Photodynamic Therapy and Microvesicles

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03960125
Recruitment Status : Not yet recruiting
First Posted : May 22, 2019
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
Jeffrey B. Travers, MD, PhD, Wright State Physicians

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.

Condition or disease Intervention/treatment Phase
Photodynamic Therapy Microvesicle Particle Device: Photodynamic Therapy Drug: 4% Imipramine Drug: Base Cream Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Photodynamic Therapy and Microvesicles
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


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




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

  2. Change in Microvesicle Particle Levels From Baseline with 4% Imipramine Cream Treatment. [ Time Frame: Day 2 ]
    PI will assess change from baseline using three 5 mm punch biopsies.


Secondary Outcome Measures :
  1. Change in Erythema From Baseline Due to Photodynamic Therapy [ Time Frame: Day 2 ]
    PI will assess change from baseline by using a non-invasive mexameter.

  2. Change in Skin Pain From Baseline Due to Photodynamic Therapy [ Time Frame: Day 2 ]
    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)

  3. Change in Itch From Baseline Due to Photodynamic Therapy [ Time Frame: Day 2 ]
    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)



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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03960125


Contacts
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Contact: Manager, Clinical Research Operations 937-245-7500 pturesearch@wrightstatephysicians.org
Contact: Regulatory Specialist 937-245-7500 pturesearch@wrightstatephysicians.org

Locations
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United States, Ohio
Wright State Physicians
Fairborn, Ohio, United States, 45324
Contact: Manager, Clinical Research Operations    937-245-7500    pturesearch@wrightstatephysicians.org   
Contact: Regulatory Specialist    937-245-7500    pturesearch@wrightstatephysicians.org   
Sponsors and Collaborators
Jeffrey B. Travers, MD, PhD
Investigators
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Principal Investigator: Jeffrey B Travers, MD, PhD Wright State Physicians
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Responsible Party: Jeffrey B. Travers, MD, PhD, Chair of Department of Pharmacology and Toxicology and Professor of Dermatology for Boonshoft School of Medicine at Wright State University, Wright State Physicians
ClinicalTrials.gov Identifier: NCT03960125    
Other Study ID Numbers: 06714
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020

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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
Additional relevant MeSH terms:
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Imipramine
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs