NCT06778434 · VA Office of Research and Development
The Effect of Topical Imipramine on Photodynamic Therapy-Mediated Immunosuppression on Forearms or Face on US Veterans
What this study is about
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.
View original scientific description
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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Dayton, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 22, 2025 · Source of record for eligibility and locations