NCT06778434 The Effect of Topical Imipramine on Photodynamic Therapy-Mediated Immunosuppression on Forearms or Face on US Veterans
| NCT ID | NCT06778434 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | VA Office of Research and Development |
| Condition | Actinic Keratosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2029-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 48 participants in total. It began in 2025-04-01 with a primary completion date of 2029-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Jeffrey Travers, MD
PRINCIPAL INVESTIGATOR
Dayton VA Medical Center, Dayton, OH
Frequently Asked Questions
Who can join the NCT06778434 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Actinic Keratosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06778434 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06778434 currently recruiting?
Yes, NCT06778434 is actively recruiting participants. Contact the research team at craig.rohan@va.gov for enrollment information.
Where is the NCT06778434 trial being conducted?
This trial is being conducted at Dayton, United States.
Who is sponsoring the NCT06778434 clinical trial?
NCT06778434 is sponsored by VA Office of Research and Development. The principal investigator is Jeffrey Travers, MD at Dayton VA Medical Center, Dayton, OH. The trial plans to enroll 48 participants.