A Phase 1 interventional study of Imipramine and Vehicle in Imipramine, Photodynamic Therapy and Actinic Keratosis, sponsored by Wright State University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Wright State University · Phase 1, Interventional, and Other
The purpose of this study is testing the use of topical Imipramine in combination with topical photodynamic therapy's (PDT) effect on pain following treatment. PDT is a commonly used treatment in dermatology for patients who have many pre-cancers (actinic keratosis-AKs) on their skin. These are both FDA-approved treatments, but this study is evaluating their use in combination, which has not been evaluated in the past. The investigators have been doing studies using animals that suggest that imipramine might make the PDT less painful and might help it work better. In order to participate, the subject and their dermatologist have decided that they would benefit from PDT to treat their skin due to many AK precancerous lesions. Please note that neither PDT nor imipramine are experimental treatments, but treating their skin with imipramine before PDT is a new approach.
343 studies on the registry are indexed under Keratosis, Actinic; 29 are open to participants now.
This study's planned enrollment of 24 is below the median of 60 across 295 interventional studies indexed under Keratosis, Actinic.
Browse Keratosis, Actinic studies →Wright State University is the lead sponsor of 39 studies on the registry; 13 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Topical 4% Imipramine
Drug: Imipramine
Vehicle
Other: Vehicle
Topical 4% Imipramine
Vehicle
Number of precancerous actinic keratosis present from baseline.
Principal investigator assesses this from AK lesion count mapping at baseline and in 6 months.
Time frame: 6 months post PDT treatment
Change in pain level due to photodynamic therapy (PDT) from baseline.
The visual analog pain scale is used to assess this outcome. (0 = no skin pain to 10 = severe skin pain)
Time frame: Immediately post PDT treatment
Change in pain level due to photodynamic therapy (PDT) from baseline.
The visual analog pain scale is used to assess this outcome. (0 = no skin pain to 10 = severe skin pain)
Time frame: 10 minutes post PDT treatment
Change in pain level due to photodynamic therapy (PDT) from baseline.
The visual analog pain scale is used to assess this outcome. (0 = no skin pain to 10 = severe skin pain)
Time frame: 30 minutes post PDT treatment
Change in pain level due to photodynamic therapy (PDT) from baseline.
The visual analog pain scale is used to assess this outcome. (0 = no skin pain to 10 = severe skin pain)
Time frame: 6 months post PDT treatment
Change in itch level due to photodynamic therapy (PDT) from baseline.
The visual analog itch scale will be used to assess this outcome. (0 = no skin itch to 10 = severe skin itch)
Time frame: Immediately post PDT treatment
Change in itch level due to photodynamic therapy (PDT) from baseline.
The visual analog itch scale will be used to assess this outcome. (0 = no skin itch to 10 = severe skin itch)
Time frame: 10 minutes post PDT treatment
Change in itch level due to photodynamic therapy (PDT) from baseline.
The visual analog itch scale will be used to assess this outcome. (0 = no skin itch to 10 = severe skin itch)
Time frame: 30 minutes post PDT treatment
Change in itch level due to photodynamic therapy (PDT) from baseline.
The visual analog itch scale will be used to assess this outcome. (0 = no skin itch to 10 = severe skin itch)
Time frame: 6 months post PDT treatment
PDFs hosted by the registry, ClinicalTrials.gov.
Started Jan 2023 (actual). Primary completion is estimated for Mar 2028, 62 months after the start.
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Studies of the drug tested here: Imipramine
Wright State University