Actively Recruiting
Pilot Study of Topical Imipramine Cream to Reduce UVB-Induced Microvesicle Release and Skin Redness in Photosensitive Adults
Led by Wright State University · Updated on 2025-01-27
40
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase 1 study to evaluate whether people who have abnormal skin reactions to sunlight, known as photosensitivity, show increased levels of tiny particles called microvesicle particles (MVP) after exposure to ultraviolet B (UVB) light. The study also aims to see if applying a topical medicine called imipramine can block the release of these particles and reduce skin redness caused by UVB exposure. Participants will receive either a 4% imipramine cream or a base cream applied to a localized area of their skin. The treatments will be tested to observe their effects on UVB-induced MVP release and skin redness. The study involves monitoring changes in MVP levels and skin erythema at 4 hours and 24 hours after treatment. During the study, participants will be assessed for changes in microvesicle particle levels and skin redness in the treated areas. Researchers will measure these outcomes at specific time points after UVB exposure and topical application. The study includes adults aged 18 to 50 with self-identified photosensitivity, and participants will be monitored for safety and response to the creams throughout the trial.
CONDITIONS
Official 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 adults aged 18 to 50
- Able to give informed consent
- Have stable transportation access
- All skin types on Fitzpatrick Scale (Type I-VI)
- Self-identified photosensitivity
- Able to provide medical history and list of medications; control subjects not taking photosensitizing medications
You will not qualify if you...
- Underlying diseases affecting wound healing (e.g., uncontrolled diabetes mellitus)
- Taking photosensitizing medications (e.g., doxycycline) or anti-inflammatories (e.g., NSAIDs except low-dose aspirin, steroids)
- Using imipramine or other tricyclic antidepressants (oral or cream)
- Using topical anti-inflammatory or systemic agents (e.g., prednisone)
- Large tattoos in testing areas
- Tanning bed use within last 3 months
- Photodynamic therapy or UVB treatments in last 3 months
- Female subjects who are pregnant or nursing
- History of abnormal scarring such as keloids
AI-Screening
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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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