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Topical Imipramine for Pain and Effectiveness of Photodynamic Therapy in Actinic Keratosis

This study is looking at whether a topical cream called Imipramine can reduce pain and improve how well photodynamic therapy (PDT) works for people with actinic keratosis (AKs). AKs are precancerous spots on the skin. PDT is a common treatment for many AKs. Researchers have seen in animal studies that Imipramine might make PDT less painful and more effective. This study will enroll 24 adults aged 18 or older with fair skin (Fitzpatrick type I to III) who have a doctor's order for PDT on their face, scalp, or forearms. The main goal is to see how many precancerous AKs are present six months after PDT treatment. The current status of this study is unclear.

Study design
This interventional study plans to enroll 24 participants. It is testing topical 4% Imipramine against a vehicle (a cream without the active drug).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You would be followed for six months after your PDT treatment to check the number of precancerous actinic keratosis present.

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

NCT05688904

The Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy

Recruiting
PHASE1Ages 18+Interventional
Wright State University
~24 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:ImipramineVehicle

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of precancerous actinic keratosis present from baseline.
Measured over 6 months post PDT treatment

Conditions

Imipramine
Photodynamic Therapy
Actinic Keratosis

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Actinic Keratosis

NCT05688904

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.

  • Wright State Physicians

    Fairborn, 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

  • Craig Rohan, MD · PRINCIPAL_INVESTIGATOR · Wright State University

Who to contact

Manager, Clinical Research Operations
[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

Male or female ages 18 and older
Skin type must be "Fair", Fitzpatrick type I to III, due to the presence of actinic damage in this population.
Subjects need to have a physician's order to receive PDT treatment on their face, scalp or 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.

Exclusion

Those currently taking any tricyclic antidepressants (TCAs)
Those currently taking any selective serotonin reuptake inhibitor (SSRI)
Those with porphyria
Large tattoos in the treated areas
Pregnancy or nursing
Taking any oral or topical medications that could interfere with the PDT (Appendix A)
Active rashes in the area

What this trial measures

  • Number of precancerous actinic keratosis present from baseline.6 months post PDT treatment

    Principal investigator assesses this from AK lesion count mapping at baseline and in 6 months.