Actively Recruiting
Pilot Studies Testing Use of Topical Imipramine in Reducing Ultraviolet B Induced Microvesicle Particle Release in Photosensitive Subjects
Led by Wright State University · Updated on 2025-01-27
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying individuals who have unusual reactions to sunlight, known as photosensitivity, to understand how ultraviolet B (UVB) light affects tiny particles called microvesicle particles (MVP) released from the skin. The study aims to find out if UVB exposure increases MVP levels, whether applying a topical medicine called imipramine can block this release, and if the cream can reduce skin redness caused by UVB. This is a Phase 1 pilot study sponsored by Wright State University focused on these responses in photosensitive adults. Participants will receive different treatments on UVB-exposed skin areas of the volar forearm and back. One area will be treated with 2 grams of 4% imipramine cream, another with 2 grams of a base cream without active medicine, and a third UVB-exposed area on the back will not receive any cream. These treatments are designed to compare the effects of imipramine against no treatment and the base cream. During the study, researchers will measure changes in microvesicle particle levels and skin redness at several times: 4 hours after treatment for MVP levels and skin erythema, and also 24 hours after topical imipramine application for skin redness. Participants will provide their medical history and medication list and will be monitored for skin reactions. The total participation time covers these assessments following UVB exposure and cream application.
CONDITIONS
Brief Title
Testing Use of Topical Imipramine in Reducing Ultraviolet B Induced Microvesicle Particle Release in Photosensitive Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 24 hours
Participants apply 4% imipramine cream and base cream to UVB-treated skin areas to study the effects on microvesicle particle release and skin erythema.
1 treatment visit with assessments at 4 and 24 hours post-application
Trial Site Locations
Total: 1 location
1
Wright State Physicians
Fairborn, Ohio, United States, 45324
Actively Recruiting
Research Team
M
Manager Clinical Research Operations
R
Regulatory Specialist
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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