The Effect of Topical Imipramine on Photodynamic Therapy-Mediated Immunosuppression on Forearms o… (NCT06778434) | Clinical Trial Compass
RecruitingPhase 2
The Effect of Topical Imipramine on Photodynamic Therapy-Mediated Immunosuppression on Forearms or Face on US Veterans
United States48 participantsStarted 2025-04-01
Plain-language summary
The purpose of this study is to test the use of topical imipramine in combination with topical photodynamic therapy's (PDT) effect on the effectiveness and pain immunosuppression following treatment. PDT is a commonly used treatment in dermatology for patients who have many pre-cancers (actinic keratosis or "AK") on their skin. These are both FDA-approved medications, but this study is evaluating their use in combination, which has not been evaluated in the past. The investigators have been doing studies using mice that suggest imipramine might reduce immune system suppression by PDT thus allowing it to work better. Subjects whose provider has decided that they may benefit from PDT to treat their skin due to many AK precancerous lesions will be recruited for this study. Please note that the PDT itself is not experimental, only the imipramine treatment to the skin. There is a separate informed consent for the PDT.
Who can participate
Age range
18 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:
* Adult Males and Females ages 18 and older who are patients at the Dayton VAMC Dermatology clinics
* Skin type must be "Fair", Fitzpatrick type I or II, due to the presence of actinic damage in this population.
* Subjects must have a VA physician's order to receive PDT treatment on their forearms.
* Willing to participate and understand the informed consent document.
* Willing to avoid excess sun exposure/tanning beds to the area to be treated with PDT.
* Has stable transportation to attend study visits at DVA
Exclusion Criteria:
* Currently taking any tricyclic antidepressants (TCAs)
* Currently taking any selective serotonin reuptake inhibitor (SSRI)
* Has Porphyria
* Large tattoos in areas to be tested
* Pregnancy or nursing
* Taking any oral or topical medications that could interfere with the PDT
* Active rashes in the areas
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
(Forearm Arm Only): Difference in areas of Candida antigen skin test results with PDT+ imipramine
Timeframe: 7, 30, 90 days post-PDT treatments
2
(Forearm Arm Only): Difference in redness of Candida antigen skin test results with PDT+ imipramine
Timeframe: 7, 30, 90 days post-PDT treatments
3
Difference in numbers of precancerous AK skin lesions with PDT and imipramine on the face