Acid Sphingomyelinase Inhibition to Mitigate Risks of UV Light-Induced Actinic Neoplasia and Squamous Cell Carcinoma in US Veterans

What this Trial Is About

Researchers are evaluating the use of topical imipramine combined with topical photodynamic therapy (PDT) to treat patients with many precancerous skin lesions called actinic keratosis (AK). This study focuses on whether imipramine can reduce the immune system suppression caused by PDT, potentially allowing the treatment to work better. PDT is a common dermatology treatment, and while both PDT and imipramine are FDA-approved, their combined use has not been studied before. The research is sponsored by the VA Office of Research and Development and involves US veterans with fair skin types who may benefit from PDT for AK lesions on their forearms or face. Participants receive either a 10% imipramine solution or a control vehicle applied to designated areas on their forearms and one side of their face. These treatments are applied topically for one hour before PDT. The study includes two experimental arms where the imipramine and control vehicle are applied separately on the forearms and face. The PDT treatment itself is not experimental but part of standard care, and a separate consent is required for it. During the study, participants will have skin tests to measure immune response and redness at 7, 30, and 90 days after PDT on the forearms, and the number of AK lesions will be counted on the face and forearms at 6 and 12 months post-treatment. Researchers will also assess gene profiles of the skin, post-PDT redness, and pain levels. Participants will attend multiple study visits, need to avoid excess sun exposure, and have stable transportation to the study site. The study is randomized and double-blinded, with close monitoring of skin responses and effects over time.

The Effect of Topical Imipramine on Photodynamic Therapy-Mediated Immunosuppression on Forearms or Face on US Veterans