Using Imipramine to Reduce Pain from Photodynamic Therapy for Skin Lesions
Pilot Studies Testing the Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy
This study is testing if using Imipramine with photodynamic therapy can help reduce pain for people getting treatment for actinic keratosis.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wright State University Academic / other |
| Locations | 1 site (Fairborn, Ohio) |
| Trial ID | NCT05688904 on ClinicalTrials.gov |
What this trial studies
This study tests the combination of topical Imipramine and photodynamic therapy (PDT) to assess its effect on pain management for patients with actinic keratosis. PDT is a standard dermatological treatment for precancerous skin lesions, and while both treatments are FDA-approved, their combined use has not been previously evaluated. The study aims to determine if Imipramine can enhance the effectiveness of PDT and reduce associated pain. Participants will be individuals who have been recommended PDT by their dermatologist due to multiple actinic keratosis lesions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with fair skin types and a physician's recommendation for PDT due to actinic keratosis.
Not a fit: Patients currently taking tricyclic antidepressants or selective serotonin reuptake inhibitors, or those with conditions that may interfere with PDT, will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain during PDT and improve treatment outcomes for patients with actinic keratosis.
How similar studies have performed: While PDT is a well-established treatment, the combination with Imipramine is novel and has not been previously tested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Fairborn, Ohio
- Wright State Physicians — Fairborn, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Craig Rohan, MD — Wright State University
- Study coordinator: Manager, Clinical Research Operations
- Email: pturesearch@wrightstatephysicians.org
- Phone: 937-245-7500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.