Clinical trial NCT06778434: The Effect of Topical Imipramine on Photodynamic Therapy-Mediated Immunosuppression on Forearms on US Veterans
Official title: Acid Sphingomyelinase Inhibition to Mitigate the Environmental Exposure Risks of Ultraviolet Light-Induced Actinic Neoplasia and Squamous Cell Carcinoma in US Veterans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Actinic Keratosis
Imipramine
Photodynamic Therapy
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2025-01-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


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

Primary outcomes:
measure: Difference in areas of Candida antigen skin test results with PDT+ imipramine
timeFrame: 7, 30, 90 days post-PDT treatments
measure: Difference in redness of Candida antigen skin test results with PDT+ imipramine
timeFrame: 7, 30, 90 days post-PDT treatments
Secondary outcomes:
measure: Difference in numbers of precancerous AK skin lesions with PDT + imipramine
timeFrame: 6, 12 months post-PDT treatment
measure: Difference in gene profile of skin following treatment with PDT + imipramine
timeFrame: 7 days post-PDT treatment
measure: Differences in post-PDT redness with PDT + imipramine
timeFrame: 10 min, 30 min, 24 hours post-PDT treatments
measure: Differences in post-PDT pain with PDT + imipramine
timeFrame: 10 min, 30 min, 24 hours post-PDT treatments
Other outcomes:
Locations:
city: Dayton
country: United States
facility: Dayton VA Medical Center, Dayton, OH
state: Ohio
Study officials:
affiliation: Dayton VA Medical Center, Dayton, OH
name: Jeffrey Travers, MD
role: PRINCIPAL_INVESTIGATOR
References: