The Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Imipramine Topical 4% Imipramine |
Drug: Imipramine
Topical 4% Imipramine
|
| Placebo Comparator: Vehicle Vehicle |
Other: Vehicle
Vehicle
|
Outcome Measures
Primary Outcome Measures
- Number of precancerous actinic keratosis present from baseline. [6 months post PDT treatment]
Principal investigator assesses this from AK lesion count mapping at baseline and in 6 months.
Secondary Outcome Measures
- Change in pain level due to photodynamic therapy (PDT) from baseline. [Immediately post PDT treatment]
The visual analog pain scale is used to assess this outcome.
- Change in pain level due to PDT from baseline. [10 minutes post PDT treatment]
The visual analog pain scale is used to assess this outcome.
- Change in pain level due to PDT from baseline. [30 minutes post PDT treatment]
The visual analog pain scale is used to assess this outcome.
- Change in pain level due to PDT from baseline. [6 months post PDT treatment]
The visual analog pain scale is used to assess this outcome.
- Change in itch level due to PDT from baseline. [Immediately post PDT treatment]
The visual analog pain scale will be used to assess this outcome.
- Change in itch level due to PDT from baseline. [10 minutes post PDT treatment]
The visual analog pain scale will be used to assess this outcome.
- Change in itch level due to PDT from baseline. [30 minutes post PDT treatment]
The visual analog pain scale will be used to assess this outcome.
- Change in itch level due to PDT from baseline. [6 months post PDT treatment]
The visual analog pain scale will be used to assess this outcome.
Eligibility Criteria
Criteria
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.
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Willing to participate and understand the informed consent document.
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Willing to avoid excess sun exposure/tanning beds to the area to be treated with PDT.
Exclusion Criteria:
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wright State Physicians | Fairborn | Ohio | United States | 45324 |
Sponsors and Collaborators
- Wright State University
Investigators
- Principal Investigator: Craig Rohan, MD, Wright State University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 07286