Testing Use of Topical Imipramine in Reducing Ultraviolet B Induced Microvesicle Particle Release in Photosensitive Subjects

Pilot Studies Testing Use of Topical Imipramine in Reducing Ultraviolet B Induced Microvesicle Particle Release in Photosensitive Subjects

The purpose of this study is three-fold. First, researchers will assess whether subjects who have clinically abnormal reactions to sunlight (photosensitivity) have increased levels of microvesicle particles (MVP) following ultraviolet B (UVB) treatment to localized area of skin. Second, researchers will assess if topical application of the medicine imipramine will block UVB-induced MVP release. Third, researchers will assess if the topical cream will block UVB-induced increased erythema reactions (reddening of the skin).

Study Overview

• Status: Recruiting
• Conditions: Photosensitivity; Microvesicle Particle
• Intervention / Treatment: Drug: 4% Imipramine Cream; Drug: Base Cream

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Manager Clinical Research Operations; Phone Number: 937-245-7500; Email: pturesearch@wrightstatephysicians.org
• Study Contact Backup: Name: Regulatory Specialist; Phone Number: 937-245-7500; Email: pturesearch@wrightstatephysicians.org

Study Locations

• United States
  • Ohio
    • Fairborn, Ohio, United States, 45324
      • Recruiting
      • Wright State Physicians

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Female and Male adult subjects age 18 to 50
• Must be able to give informed consent
• Have access to stable transportation
• All skin types on Fitzpatrick Scale (Type I-VI)
• Self-Identified photosensitivity
• Able to provide medical history and list of medications-control subjects will not be allowed to be taking a medication that is known to be photosensitizer.

Exclusion Criteria:

• Underlying diseases that could affect wound healing (e.g., uncontrolled diabetes mellitus)
• Taking medications that are known photosensitizers (e.g., doxycycline) or anti-inflammatories (e.g., NSAIDS [except for low-dose aspirin] or steroids)
• Utilizing imipramine or any other tricyclic antidepressant (oral or cream)
• Utilizing topical anti-inflammatory or systemic agents (e.g., prednisone)
• Large tattoos in the designated testing areas
• Tanning bed use within last 3 months
• Photodynamic Therapy or UVB treatments in past 3 months
• Female Subjects: pregnant or nursing
• History of abnormal scarring (i.e., keloids)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 4% Imipramine Cream on UVB-Treated Areas; 2g of 4% imipramine cream will be applied to the UVB-treated areas on volar forearm and back.; 2g of base cream will be applied to the UVB-treated areas on volar forearm and back.; No cream will be applied to a UVB-treated area on the back	Drug: 4% Imipramine Cream; 4% Imipramine Cream; Drug: Base Cream; Base Cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in microvesicle particle levels from baseline in clinically photosensitive subjects	This will be measured in skin biopsies obtained at 4 hours following ultraviolet B radiation fluence of 1000 J/m2.	4 Hours
Change in microvesicle particle levels from baseline post topical imipramine application	This will be measured in skin biopsies with topical imipramine applied. Biopsies are obtained at 4 hours following ultraviolet B radiation fluence of 1000 J/m2.	4 Hours
Change in skin erythema from baseline on topical imipramine treated skin	This will be measured with a mexameter at 4 hours.	4 Hours
Change in skin erythema from baseline on topical imipramine treated skin	This will be measured with a mexameter at 24 hours.	24 Hours

Collaborators and Investigators

• Sponsor: Wright State University
• Investigators: Principal Investigator: Jeffrey B Travers, MD, PhD, Wright State University

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 17, 2020
• First Submitted That Met QC Criteria: August 17, 2020
• First Posted (Actual): August 20, 2020

Study Record Updates

• Last Update Posted (Actual): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Antidepressive Agents, Tricyclic; Adrenergic Uptake Inhibitors; Imipramine
• Other Study ID Numbers: 06919

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes