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Search / Trial NCT06778434

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

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Jan 10, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a cream called imipramine when used alongside a treatment known as photodynamic therapy (PDT) for patients with actinic keratosis, which are precancerous skin lesions. PDT is a standard treatment that helps improve skin health, and researchers want to see if applying imipramine can help the immune system work better after PDT, making the treatment more effective. While both treatments are approved for use, this study is one of the first to look at how they can work together.

To participate in this study, you need to be an adult (18 years or older) and a patient at the Dayton VA Dermatology clinics with light skin (Fitzpatrick type I or II) who has been prescribed PDT for actinic keratosis on your forearms. Participants should be willing to avoid excessive sun exposure and must have reliable transportation for study visits. However, individuals currently taking certain medications, pregnant, or with specific skin conditions may not be eligible. If you join the study, you will have the opportunity to learn more about these treatments and help researchers understand how to improve care for patients with similar skin issues.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Adult Males and Females ages 18 and older who are patients at the Dayton VAMC Dermatology clinics
  • Skin type must be "Fair", Fitzpatrick type I or II, due to the presence of actinic damage in this population.
  • Subjects must have a VA physician's order to receive PDT treatment on their 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.
  • Has stable transportation to attend study visits at DVA
  • Exclusion Criteria:
  • Currently taking any tricyclic antidepressants (TCAs)
  • Currently taking any selective serotonin reuptake inhibitor (SSRI)
  • Has Porphyria
  • Large tattoos in areas to be tested
  • Pregnancy or nursing
  • Taking any oral or topical medications that could interfere with the PDT
  • Active rashes in the areas

About Va Office Of Research And Development

The VA Office of Research and Development (ORD) is dedicated to advancing the health and well-being of veterans through innovative research initiatives. As a pivotal sponsor of clinical trials, ORD focuses on a broad spectrum of health-related topics, including mental health, rehabilitation, and chronic disease management, ensuring that findings are directly applicable to the unique needs of the veteran population. With a commitment to scientific excellence and collaboration, ORD promotes rigorous study designs and ethical standards, facilitating the translation of research discoveries into improved clinical practices and policies that enhance veteran care.

Locations

Dayton, Ohio, United States

Patients applied

0 patients applied

Trial Officials

Jeffrey Travers, MD

Principal Investigator

Dayton VA Medical Center, Dayton, OH

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported