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

Phase 2RecruitingNCT06778434

VA Office of Research and Development48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Actinic Keratosis Imipramine Photodynamic Therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

(Forearm Arm Only): Difference in areas of Candida antigen skin test results with PDT+ imipramine

Size of skin reactions from baseline values will be obtained following PDT + vehicle/imipramine using calipers.

Time frame: 7, 30, 90 days post-PDT treatments

(Forearm Arm Only): Difference in redness of Candida antigen skin test results with PDT+ imipramine

Redness of skin reactions from baseline values will be obtained following PDT + vehicle/imipramine using mexameter device and thermal imaging.

Time frame: 7, 30, 90 days post-PDT treatments

Difference in numbers of precancerous AK skin lesions with PDT and imipramine on the face

Differences in baseline values of AK will be obtained following PDT + vehicle/imipramine by counting and mapping on each side of face/scalp.

Time frame: 6, 12 months post-PDT treatment

Secondary Outcomes

Difference in numbers of precancerous AK skin lesions with PDT and imipramine on the forearms

Differences in baseline values of AK will be obtained following PDT + vehicle/imipramine by counting and mapping each forearm/wrist.

Time frame: 6, 12 months post-PDT treatment

(Forearm Arm Only): Difference in gene profile of skin following treatment with PDT + imipramine

Differences in transcriptome RNA values from baseline will be obtained following PDT + vehicle/impramine by use of tissue RNA-seq with a commercial dermal transcriptomal patch.

Time frame: 7 days post-PDT treatment

Differences in post-PDT redness with PDT + imipramine

Differences in redness following PDT + imipramine vs PDT + vehicle from baseline values will be obtained using a mexameter device and thermal imaging on face/forearms.

Time frame: 10 min, 30 min, 24 hours post-PDT treatments

Differences in post-PDT pain with PDT + imipramine

Differences in pain following PDT + imipramine vs PDT + vehicle from baseline values will be obtained using a visual analog scale on face/forearms.