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Photodynamic Therapy and Microvesicles

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ClinicalTrials.gov Identifier: NCT03960125
Recruitment Status : Not yet recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Jeffrey B. Travers, MD, PhD, Wright State Physicians

Brief Summary:

This study is designed to test whether localized PDT treatment will result in increased skin levels of MVP and if the use of imipramine will counteract PDT generated MVP release. The effects of PDT and UVB on PAF and MVP production have long been part of the PI's research experience. To test this, we plan 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.

Our hypothesis is that PDT will generate MVP in human skin in vivo, and topical imipramine will block this effect. We also believe that topical imipramine will block both early as well as delayed redness (erythema reactions).


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 : July 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 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.

  3. Change in Itch From Baseline Due to Photodynamic Therapy [ Time Frame: Day 2 ]
    PI will assess change with the Itch Numerical Scale.



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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
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 Not yet recruiting
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     History of Changes
Other Study ID Numbers: Temp-1473
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
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