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| ID | Type | Description | Link |
|---|---|---|---|
| IRB-2024-639 | Other Identifier | Wright State University IRB | |
| IRB-2024-674 | Other Identifier | Wright State University IRB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imipramine and Control Vehicle on Forearms | Experimental | 10% imipramine and control vehicle (1.5 ml each) are applied on designated separate dorsal forearm. |
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| Imipramine and Control Vehicle on Face | Experimental | 10% imipramine and control vehicle (1.5 ml each) are applied on one side of the face for 1 hour. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imipramine | Drug | 10% imipramine |
|
| Measure | Description | Time Frame |
|---|---|---|
| (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. | 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. | 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. | 6, 12 months post-PDT treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6, 12 months post-PDT treatment |
| (Forearm Arm Only): Difference in gene profile of skin following treatment with PDT + imipramine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Craig A Rohan, MD | Contact | (937) 245-7500 | craig.rohan@va.gov | |
| Jeffrey Travers, MD | Contact | (937) 268-6511 | 2026 | Jeffrey.Travers@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Travers, MD | Dayton VA Medical Center, Dayton, OH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dayton VA Medical Center, Dayton, OH | Recruiting | Dayton | Ohio | 45428 | United States |
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| Control Vehicle | Other | polyethylene glycol: dimethyl sulfoxide Solution |
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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. |
| 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. | 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. | 10 min, 30 min, 24 hours post-PDT treatments |
| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D007099 | Imipramine |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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