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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 : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
Jeffrey B. Travers, MD, PhD, Wright State Physicians

Tracking Information
First Submitted Date  ICMJE May 20, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date July 1, 2020
Estimated Study Start Date  ICMJE September 2020
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2019)
  • 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.
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • 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.
  • 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.
  • Change in Itch From Baseline Due to Photodynamic Therapy [ Time Frame: Day 2 ]
    PI will assess change with the Itch Numerical Scale.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Photodynamic Therapy and Microvesicles
Official Title  ICMJE Photodynamic Therapy and Microvesicles
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Photodynamic Therapy
  • Microvesicle Particle
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 4% Imipramine Cream on Upper Forearm Site
    Base cream will be applied to the lower forearm site.
    Interventions:
    • Device: Photodynamic Therapy
    • Drug: 4% Imipramine
    • Drug: Base Cream
  • Experimental: 4% Imipramine Cream on Lower Forearm Site
    Base cream will be applied to the upper forearm site.
    Interventions:
    • Device: Photodynamic Therapy
    • Drug: 4% Imipramine
    • Drug: Base Cream
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 20, 2019)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Manager, Clinical Research Operations 937-245-7500 pturesearch@wrightstatephysicians.org
Contact: Regulatory Specialist 937-245-7500 pturesearch@wrightstatephysicians.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03960125
Other Study ID Numbers  ICMJE 06714
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeffrey B. Travers, MD, PhD, Wright State Physicians
Study Sponsor  ICMJE Jeffrey B. Travers, MD, PhD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeffrey B Travers, MD, PhD Wright State Physicians
PRS Account Wright State Physicians
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP