Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06778434

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

Led by VA Office of Research and Development · Updated on 2025-12-22

48

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to test the use of topical imipramine in combination with topical photodynamic therapy's (PDT) effect on the effectiveness and pain immunosuppression following treatment. PDT is a commonly used treatment in dermatology for patients who have many pre-cancers (actinic keratosis or "AK") on their skin. These are both FDA-approved medications, but this study is evaluating their use in combination, which has not been evaluated in the past. The investigators have been doing studies using mice that suggest imipramine might reduce immune system suppression by PDT thus allowing it to work better. Subjects whose provider has decided that they may benefit from PDT to treat their skin due to many AK precancerous lesions will be recruited for this study. Please note that the PDT itself is not experimental, only the imipramine treatment to the skin. There is a separate informed consent for the PDT.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older who are patients at the Dayton VAMC Dermatology clinics
  • Fair skin type, Fitzpatrick type I or II, with actinic damage
  • Have a VA physician's order for PDT treatment on the forearms
  • Willing to participate and understand the informed consent
  • Willing to avoid excess sun exposure or tanning beds on the treatment area
  • Have stable transportation to attend study visits at DVA
Not Eligible

You will not qualify if you...

  • Currently taking any tricyclic antidepressants (TCAs)
  • Currently taking any selective serotonin reuptake inhibitors (SSRIs)
  • Have porphyria
  • Have large tattoos in the treatment areas
  • Are pregnant or nursing
  • Taking any oral or topical medications that could interfere with PDT
  • Have active rashes in the treatment areas

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Dayton VA Medical Center, Dayton, OH

Dayton, Ohio, United States, 45428

Actively Recruiting

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Research Team

C

Craig A Rohan, MD

CONTACT

J

Jeffrey Travers, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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