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

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Minor 2 versions Re-verified since Apr 23, 2024, no change to tracked fieldsv5-v6
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2023 to Jan 19, 2023
    • Site details revised
    v4
  3. Minor Re-verified, no change to tracked fieldsv3
  4. Minor Secondary endpoints revised (8)v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05688904
Lead Sponsor Wright State University
Conditions
(from sponsor)
Imipramine, Photodynamic Therapy, Actinic Keratosis
Related terms Keratosis, Actinic
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov