RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to test the use of topical imipramine in combination with topical photodynamic therapy's (PDT) effect on 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.

Official Title

Acid Sphingomyelinase Inhibition to Mitigate the Environmental Exposure Risks of Ultraviolet Light-Induced Actinic Neoplasia and Squamous Cell Carcinoma in US Veterans

Quick Facts

Study Start:2025-04-01
Study Completion:2029-03-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06778434

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult Males and Females ages 18 and older who are patients at the Dayton VAMC Dermatology clinics
  2. * Skin type must be "Fair", Fitzpatrick type I or II, due to the presence of actinic damage in this population.
  3. * Subjects must have a VA physician's order to receive PDT treatment on their forearms.
  4. * Willing to participate and understand the informed consent document.
  5. * Willing to avoid excess sun exposure/tanning beds to the area to be treated with PDT.
  6. * Has stable transportation to attend study visits at DVA
  1. * Currently taking any tricyclic antidepressants (TCAs)
  2. * Currently taking any selective serotonin reuptake inhibitor (SSRI)
  3. * Has Porphyria
  4. * Large tattoos in areas to be tested
  5. * Pregnancy or nursing
  6. * Taking any oral or topical medications that could interfere with the PDT
  7. * Active rashes in the areas

Contacts and Locations

Study Contact

Craig A Rohan, MD
CONTACT
(937) 245-7500
craig.rohan@va.gov
Jeffrey Travers, MD
CONTACT
(937) 268-6511
Jeffrey.Travers@va.gov

Principal Investigator

Jeffrey Travers, MD
PRINCIPAL_INVESTIGATOR
Dayton VA Medical Center, Dayton, OH

Study Locations (Sites)

Dayton VA Medical Center, Dayton, OH
Dayton, Ohio, 45428
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Jeffrey Travers, MD, PRINCIPAL_INVESTIGATOR, Dayton VA Medical Center, Dayton, OH

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-01
Study Completion Date2029-03-30

Study Record Updates

Study Start Date2025-04-01
Study Completion Date2029-03-30

Terms related to this study

Additional Relevant MeSH Terms

  • Actinic Keratosis
  • Imipramine
  • Photodynamic Therapy