RecruitingPhase 2NCT06778434

The Effect of Topical Imipramine on Photodynamic Therapy-Mediated Immunosuppression on Forearms or Face on US Veterans

Acid Sphingomyelinase Inhibition to Mitigate the Environmental Exposure Risks of Ultraviolet Light-Induced Actinic Neoplasia and Squamous Cell Carcinoma in US Veterans

Sponsor

VA Office of Research and Development

Enrollment

48 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

Photodynamic Therapy Actinic Keratosis Imipramine

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a cream containing a medication called imipramine to see if it can protect skin from immune suppression caused by photodynamic therapy (PDT) — a light-based treatment used to treat damaged or precancerous skin. The study is being conducted at a VA medical center and focuses on veterans with sun-damaged skin. **You may be eligible if...** - You are an adult (18 or older) and a patient at the Dayton VA Medical Center dermatology clinic - You have fair skin (Fitzpatrick type I or II) - You have a doctor's order for PDT treatment on your forearms - You are willing to limit sun exposure during the study - You have reliable transportation to attend study visits **You may NOT be eligible if...** - You are currently taking tricyclic antidepressants (TCAs) or SSRIs (like fluoxetine or sertraline) - You have porphyria (a rare blood condition) - You have large tattoos in the areas to be tested - You are pregnant or breastfeeding - You take certain medications that could interact with the study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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