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The PI decided to move in another direction with his research.
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This study is designed to test whether localized photodynamic therapy (PDT) treatment will result in increased skin levels of microvesicle particle (MVP) and if the use of imipramine will counteract PDT generated MVP release. The effects of PDT and ultraviolet B radiation (UVB) on platelet-activating factor (PAF) and MVP production have long been part of the PI's research experience. To test this, the investigator plans to enroll up to enroll up to 12 male subjects whom are aged 21 to age 45. These subjects will be treated with topical 5-aminolevulinic acid gel (Ameluz) to small areas of forearm followed by treatment with blue light. The areas will then be treated with either 4% imipramine cream or cream base as control. Four hours later, the redness of the areas will be measured using a mexameter and MVPs measured in skin biopsies taken from PDT-treated skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4% Imipramine Cream on Upper Forearm Site | Experimental | Base cream will be applied to the lower forearm site. |
|
| 4% Imipramine Cream on Lower Forearm Site | Experimental | Base cream will be applied to the upper forearm site. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photodynamic Therapy | Device | Blue Light Therapy Exposure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Microvesicle Particle Levels From Baseline with Photodynamic Therapy. | PI will assess change from baseline using three 5 mm punch biopsies. | Day 0 |
| Change in Microvesicle Particle Levels From Baseline with 4% Imipramine Cream Treatment. | PI will assess change from baseline using three 5 mm punch biopsies. | Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Erythema From Baseline Due to Photodynamic Therapy | PI will assess change from baseline by using a non-invasive mexameter. | Day 2 |
| Change in Skin Pain From Baseline Due to Photodynamic Therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey B Travers, MD, PhD | Wright State Physicians | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wright State Physicians | 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 | Jul 19, 2021 | Sep 7, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D010778 | Photochemotherapy |
| D007099 | Imipramine |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D010789 | Phototherapy |
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| 4% Imipramine | Drug | A tricyclic antidepressant (TCA) medication. Though it is usually taken orally, topical preparations (4%) has use in topical anesthetics and anti-pain medicaments. |
|
| Base Cream | Drug | Control to 4% Imipramine |
|
PI will assess change with the Skin Pain Visual Analogue Scale. Participants indicate the overall severity of skin pain from the photodynamic therapy treatment at the present time by placing a single mark on the horizontal scale (0 = no skin pain to 10 = severe skin pain)
| Day 2 |
| Change in Itch From Baseline Due to Photodynamic Therapy | PI will assess change with the Itch Numerical Scale. Participants will rate itching severity due to photodynamic therapy treatment by circling the number that best describes the worst level of itching in the past 24 hours. (0 = No itch to 10 = Worst itch imaginable) | Day 2 |
| D003984 |
| Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |