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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
24
Topical 4% Imipramine
Vehicle
Wright State Physicians
Fairborn, Ohio, United States
RECRUITINGNumber 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
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 6 months post PDT treatment
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