The Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Studies Testing the Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy

Conditions
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Imipramine, Photodynamic Therapy, Actinic Keratosis

Intervention / Treatment
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* Drug: Imipramine
* Other: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female ages 18 and older Skin type must be Fair, Fitzpatrick type I to III, due to the presence of actinic damage in this population. Subjects need to have a physician's order to receive PDT treatment on their face, scalp or 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. Exclusion Criteria: Those currently taking any tricyclic antidepressants (TCAs) Those currently taking any selective serotonin reuptake inhibitor (SSRI) Those with porphyria Large tattoos in the treated areas Pregnancy or nursing Taking any oral or topical medications that could interfere with the PDT (Appendix A) Active rashes in the area

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Imipramine<br>Topical 4% Imipramine | Drug: Imipramine<br>* Topical 4% Imipramine<br>|
| Placebo Comparator: Vehicle<br>Vehicle | Other: Vehicle<br>* Vehicle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |