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

Recruiting now · Phase 2

Conditions studied: Actinic Keratosis, Imipramine, Photodynamic Therapy

In brief

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.

Key facts

Study ID

NCT06778434

Run by

VA Office of Research and Development

People needed

48

Starts

2025-04-01

Expected to finish

2029-03-30

Last updated by the study team

2025-12-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dayton VA Medical Center, Dayton, OH — Dayton, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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