About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Currently taking any tricyclic antidepressants (TCAs)
Currently taking any selective serotonin reuptake inhibitor (SSRI)
Has Porphyria
Large tattoos in areas to be tested
Trial design
Parallel
Treatments tested in this trial
Imipramine
Drug10% imipramine
Control Vehicle
Other interventionpolyethylene glycol: dimethyl sulfoxide Solution
Treatment groups
Trial 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.
(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.
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.
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.
(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.
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.
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.
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