Clinical Trial

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

Recruiting Phase 1
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Summary
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-01-09; most recent amendment 2024-04-23.
Status change: Not Yet Recruiting → Recruiting 2023-04-18
Trial Details
NCT Number NCT05688904
Lead Sponsor Wright State University
Conditions Imipramine, Photodynamic Therapy, Actinic Keratosis
Enrollment 24 participants
Start Date 2023-01-19
Primary Completion 2028-03 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2024-04-24