Pilot Study of Topical Imipramine to Reduce Pain and Improve Effectiveness of Photodynamic Therapy for Actinic Keratosis

What this Trial Is About

Researchers are studying the combined use of topical Imipramine and topical photodynamic therapy PDT to see if this combination affects pain after treatment. PDT is a common dermatology treatment for people with many precancerous skin lesions called actinic keratosis AK. Both Imipramine and PDT are FDA-approved treatments, but their combined use has not been evaluated before. Animal studies suggest Imipramine might reduce pain from PDT and improve its effectiveness. Participants will receive either topical 4% Imipramine or a placebo vehicle before PDT treatment. The study is randomized and double-blinded, meaning participants are randomly assigned to one of the two treatment groups without knowing which they receive. The treatments will be applied to areas such as the face, scalp, or forearms where PDT is needed. During the study, participants will be monitored for pain and itch levels immediately after PDT treatment, at 10 minutes, 30 minutes, and again at 6 months post-treatment. The main measure is the number of precancerous AK lesions remaining six months after PDT. The study will track safety and treatment effects over this time, ensuring participants understand the process and follow sun exposure precautions. The total study duration extends up to six months post-treatment.

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