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Topical Imipramine with Photodynamic Therapy for Actinic Keratosis

This study is looking at how a cream called imipramine, when used with photodynamic therapy (PDT), affects the treatment of actinic keratosis (AK), which are precancerous skin lesions. PDT is a common treatment for AK, and imipramine is an FDA-approved medication. Researchers want to see if combining them can make PDT more effective by reducing its impact on your immune system. You may be able to join if you are an adult veteran (18 or older) with fair skin (Fitzpatrick type I or II) who has many AKs and a VA doctor has ordered PDT for your forearms. The study will measure differences in skin test results and the number of AK lesions on your face after treatment. The current status of this study is unclear, and it plans to enroll 48 participants.

Study design
This is an interventional study. It plans to enroll 48 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
For forearm treatments, you would be followed for 7, 30, and 90 days after PDT. For face treatments, you would be followed for 6 and 12 months after PDT.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06778434

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

Recruiting
PHASE2Ages 18+InterventionalBasic science
VA Office of Research and Development
~48 participants
Updated 2025-12-22 on ClinicalTrials.gov
What's tested:ImipramineControl Vehicle

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
(Forearm Arm Only): Difference in areas of Candida antigen skin test results with PDT+ imipramine
Measured over 7, 30, 90 days post-PDT treatments
+2 more outcomes measured

Conditions

Actinic Keratosis
Imipramine
Photodynamic Therapy

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Actinic Keratosis

NCT06778434

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Dayton VA Medical Center, Dayton, OH

    Dayton, Ohiostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jeffrey Travers, MD · PRINCIPAL_INVESTIGATOR · Dayton VA Medical Center, Dayton, OH

Who to contact

Craig A Rohan, MD
[email protected]
(937) 245-7500
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • (Forearm Arm Only): Difference in areas of Candida antigen skin test results with PDT+ imipramine7, 30, 90 days post-PDT treatments

    Size of skin reactions from baseline values will be obtained following PDT + vehicle/imipramine using calipers.

  • (Forearm Arm Only): Difference in redness of Candida antigen skin test results with PDT+ imipramine7, 30, 90 days post-PDT treatments

    Redness of skin reactions from baseline values will be obtained following PDT + vehicle/imipramine using mexameter device and thermal imaging.

  • Difference in numbers of precancerous AK skin lesions with PDT and imipramine on the face6, 12 months post-PDT treatment

    Differences in baseline values of AK will be obtained following PDT + vehicle/imipramine by counting and mapping on each side of face/scalp.