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The purpose of this study is testing the use of topical Imipramine in combination with topical photodynamic therapy's (PDT) effect on pain following treatment. PDT is a commonly used treatment in dermatology for patients who have many pre-cancers (actinic keratosis-AKs) on their skin. These are both FDA-approved treatments, but this study is evaluating their use in combination, which has not been evaluated in the past. The investigators have been doing studies using animals that suggest that imipramine might make the PDT less painful and might help it work better. In order to participate, the subject and their dermatologist have decided that they would benefit from PDT to treat their skin due to many AK precancerous lesions. Please note that neither PDT nor imipramine are experimental treatments, but treating their skin with imipramine before PDT is a new approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imipramine | Active Comparator | Topical 4% Imipramine |
|
| Vehicle | Placebo Comparator | Vehicle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imipramine | Drug | Topical 4% Imipramine |
| |
| Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Number of precancerous actinic keratosis present from baseline. | Principal investigator assesses this from AK lesion count mapping at baseline and in 6 months. | 6 months post PDT treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain level due to photodynamic therapy (PDT) from baseline. | The visual analog pain scale is used to assess this outcome. (0 = no skin pain to 10 = severe skin pain) | Immediately post PDT treatment |
| Change in pain level due to photodynamic therapy (PDT) from baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manager, Clinical Research Operations | Contact | 937-245-7500 | pturesearch@wrightstatephysicians.org | |
| Regulatory Specialist | Contact | 937-245-7500 | pturesearch@wrightstatephysicians.org |
| Name | Affiliation | Role |
|---|---|---|
| Craig Rohan, MD | Wright State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wright State Physicians | Recruiting | Fairborn | Ohio | 45324 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 6, 2023 | Feb 20, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin 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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| Other |
Vehicle |
|
The visual analog pain scale is used to assess this outcome. (0 = no skin pain to 10 = severe skin pain) |
| 10 minutes post PDT treatment |
| Change in pain level due to photodynamic therapy (PDT) from baseline. | The visual analog pain scale is used to assess this outcome. (0 = no skin pain to 10 = severe skin pain) | 30 minutes post PDT treatment |
| Change in pain level due to photodynamic therapy (PDT) from baseline. | The visual analog pain scale is used to assess this outcome. (0 = no skin pain to 10 = severe skin pain) | 6 months post PDT treatment |
| Change in itch level due to photodynamic therapy (PDT) from baseline. | The visual analog itch scale will be used to assess this outcome. (0 = no skin itch to 10 = severe skin itch) | Immediately post PDT treatment |
| Change in itch level due to photodynamic therapy (PDT) from baseline. | The visual analog itch scale will be used to assess this outcome. (0 = no skin itch to 10 = severe skin itch) | 10 minutes post PDT treatment |
| Change in itch level due to photodynamic therapy (PDT) from baseline. | The visual analog itch scale will be used to assess this outcome. (0 = no skin itch to 10 = severe skin itch) | 30 minutes post PDT treatment |
| Change in itch level due to photodynamic therapy (PDT) from baseline. | The visual analog itch scale will be used to assess this outcome. (0 = no skin itch to 10 = severe skin itch) | 6 months post PDT treatment |
| D017437 |
| Skin and Connective Tissue Diseases |