NCT04520217PHASE1RecruitingAccepts Healthy Volunteers
Testing Use of Topical Imipramine in Reducing Ultraviolet B Induced Microvesicle Particle Release in Photosensitive Subjects
Wright State University
Start Date
6/6/2022
Completion Date
12/1/2026
Summary
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).
Eligibility Criteria
Age Range: 18 years to 50 years
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)
Interventions
DRUG
4% Imipramine Cream
DRUG
Base Cream
Conditions
PhotosensitivityMicrovesicle Particle
Locations
Wright State Physicians
Fairborn, Ohio 45324
United States