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

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.

Conditions

Actinic Keratosis, Imipramine, Photodynamic Therapy

Study Overview

Study Details

Study overview

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.

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

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

Condition
Actinic Keratosis
Intervention / Treatment

-

Contacts and Locations

Dayton

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

VA Office of Research and Development,

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

Study Record Dates

2029-03-30