NCT05688904 The Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy
| NCT ID | NCT05688904 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Wright State University |
| Condition | Imipramine |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2023-01-19 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2023-01-19 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Craig Rohan, MD
PRINCIPAL INVESTIGATOR
Wright State University
Frequently Asked Questions
Who can join the NCT05688904 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Imipramine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05688904 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05688904 currently recruiting?
Yes, NCT05688904 is actively recruiting participants. Contact the research team at pturesearch@wrightstatephysicians.org for enrollment information.
Where is the NCT05688904 trial being conducted?
This trial is being conducted at Fairborn, United States.
Who is sponsoring the NCT05688904 clinical trial?
NCT05688904 is sponsored by Wright State University. The principal investigator is Craig Rohan, MD at Wright State University. The trial plans to enroll 24 participants.