Pilot Studies Testing the Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy
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.
Arms & interventions
- DrugImipramine
Topical 4% Imipramine
- OtherVehicle
Vehicle
Outcome measures
Primary
Number of precancerous actinic keratosis present from baseline.
Principal investigator assesses this from AK lesion count mapping at baseline and in 6 months.
Time frame: 6 months post PDT treatment
Secondary
Change in pain level due to photodynamic therapy (PDT) from baseline.
Time frame: Immediately post PDT treatment
Change in pain level due to photodynamic therapy (PDT) from baseline.
Time frame: 10 minutes post PDT treatment
Change in pain level due to photodynamic therapy (PDT) from baseline.
Time frame: 30 minutes post PDT treatment
Change in pain level due to photodynamic therapy (PDT) from baseline.
Time frame: 6 months post PDT treatment
Change in itch level due to photodynamic therapy (PDT) from baseline.
Time frame: Immediately post PDT treatment
Change in itch level due to photodynamic therapy (PDT) from baseline.
Time frame: 10 minutes post PDT treatment
Change in itch level due to photodynamic therapy (PDT) from baseline.
Time frame: 30 minutes post PDT treatment
Change in itch level due to photodynamic therapy (PDT) from baseline.
Time frame: 6 months post PDT treatment
Eligibility criteria
Study locations (1)
Wright State Physicians
Fairborn, Ohio, 45324