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NCT05688904 · ClinicalTrials.gov registry record · Phase 1
The Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy
A Phase 1 study of Actinic Keratosis and Imipramine, sponsored by Wright State University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT05688904: Recruiting Phase 1 study of Actinic Keratosis and Imipramine, sponsored by Wright State University.
NCT05688904 is a Phase 1 study of Actinic Keratosis and Imipramine that is actively recruiting participants, run by Wright State University. The registered enrollment target is 24 participants, below the 187-participant average among 16 other Actinic Keratosis trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05688904, a Phase 1 study of Actinic Keratosis and Imipramine, is actively recruiting participants, sponsored by Wright State University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Principal investigator assesses this from AK lesion count mapping at baseline and in 6 months.
Conditions Studied
Interventions
- DRUG Imipramine
- OTHER Vehicle
Study Locations (1)
Ohio
- Wright State Physicians - Fairborn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2023-01-19 |
| Est. Completion | 2028-03 |
| Phase | Phase 1 |
What NCT05688904 shows while recruiting
NCT05688904 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 187-participant average among 16 other Actinic Keratosis trials with a reported enrollment target (87% lower).
The record links to 3 conditions, with Actinic Keratosis appearing as the primary indexed condition, and to 2 interventions - of which Imipramine is the first listed.
NCT05688904 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT05688904 about?
NCT05688904 is a clinical study titled "The Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy". 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...
What is the current status of trial NCT05688904?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2023-01-19. Estimated completion is 2028-03.
What conditions does trial NCT05688904 study?
This clinical trial studies the following conditions: Actinic Keratosis, Imipramine, Photodynamic Therapy.
What interventions are being tested in trial NCT05688904?
The interventions under investigation include: Imipramine (DRUG), Vehicle (OTHER).
Who is sponsoring clinical trial NCT05688904?
This trial is sponsored by Wright State University, which has 32 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05688904 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Actinic Keratosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05688904's enrollment target sits among peer trials
24 15th of 16 higher than 2 of 16 other Actinic Keratosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Actinic Keratosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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