Testing Use of Topical Imipramine in Reducing Ultraviolet B Induced Microvesicle Particle Release… (NCT04520217) | Clinical Trial Compass
RecruitingPhase 1
Testing Use of Topical Imipramine in Reducing Ultraviolet B Induced Microvesicle Particle Release in Photosensitive Subjects
United States40 participantsStarted 2022-06-06
Plain-language 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).
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in microvesicle particle levels from baseline in clinically photosensitive subjects
Timeframe: 4 Hours
2
Change in microvesicle particle levels from baseline post topical imipramine application
Timeframe: 4 Hours
3
Change in skin erythema from baseline on topical imipramine treated skin
Timeframe: 4 Hours
4
Change in skin erythema from baseline on topical imipramine treated skin